Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

Evidence summary

K213583 reports MR system, software, image-quality, and reader validation for the cleared configurations. The public FDA package does not establish one release-wide diagnostic sensitivity or specificity value; the exact scanner, field strength, coil, sequence, SmartSpeed option, and MRE pathway must be matched before using family material.

FDA source Exact FDA submission Checked 2026-09-03

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

31 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K213583. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-1954-2026 is Open, Classified for Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1955-2026 is Open, Classified for Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1956-2026 is Open, Classified for Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1960-2026 is Open, Classified for Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1961-2026 is Open, Classified for Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1966-2026 is Open, Classified for Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1967-2026 is Open, Classified for Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1968-2026 is Open, Classified for Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1969-2026 is Open, Classified for Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.. FDA reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. FDA action: Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form. FDA recall Z-1204-2026 is Open, Classified for Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.. FDA reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). FDA action: Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620). FDA recall Z-1205-2026 is Open, Classified for Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.. FDA reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). FDA action: Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620). FDA recall Z-1210-2026 is Open, Classified for Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.. FDA reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). FDA action: Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620). FDA recall Z-1215-2026 is Open, Classified for SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.. FDA reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). FDA action: Philips began notification of consignees on about 12/03/2025 via mailed Urgent Medical Device Correction letter, with a corrected notification sent on about 12/18/2025. Consignees were instructed to identify if any affected units were on hand, that the systems could continue to be use in accordance with their intended use. They were asked to provide the notification to all users of the device for awareness, maintain the Urgent Medical Device Correction letter with affected systems until the software upgrade is installed, and complete and return the provided response form. A Philips representative will contact each consignee to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues beginning in January 2026 (reference FCO78100585, FCO78100620). FDA recall Z-2204-2025 is Open, Classified for Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;. FDA reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. FDA action: On June 30, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users 4.1. When using any affected system identified according to the information in section 3, follow the instructions below. 4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is encountered, which may appear in the user interface (UI) with the symbols shown in Figure 4 below: Figure 4. Scan Abort Symbols 4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the message box (see Figure 5 and Figure 6 examples) 4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to expand the message box in case previous messages are hidden, see orange box in Figure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error shown and continue scanning, for example: RF door must be closed while performing scan. Scan aborted. Patient support is moved while scanning, scan stopped. Coil A (or B) failure, coil disconnected? . 4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop scanning immediately and contact Philips Service to describe the problem: If there is no error message in the message box If the error message meaning is not clear 4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row, or if the error message Gradient amplifier Rack Fault is preceded or followed by an aborted scan with no message, then stop scanning immediately and contact Philips Service to describe the problem. 4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt any additional/further scans, including without limitation do not attempt any phantom scanning until... FDA recall Z-2208-2025 is Open, Classified for Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;. FDA reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. FDA action: On June 30, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users 4.1. When using any affected system identified according to the information in section 3, follow the instructions below. 4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is encountered, which may appear in the user interface (UI) with the symbols shown in Figure 4 below: Figure 4. Scan Abort Symbols 4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the message box (see Figure 5 and Figure 6 examples) 4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to expand the message box in case previous messages are hidden, see orange box in Figure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error shown and continue scanning, for example: RF door must be closed while performing scan. Scan aborted. Patient support is moved while scanning, scan stopped. Coil A (or B) failure, coil disconnected? . 4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop scanning immediately and contact Philips Service to describe the problem: If there is no error message in the message box If the error message meaning is not clear 4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row, or if the error message Gradient amplifier Rack Fault is preceded or followed by an aborted scan with no message, then stop scanning immediately and contact Philips Service to describe the problem. 4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt any additional/further scans, including without limitation do not attempt any phantom scanning until your... FDA recall Z-2209-2025 is Open, Classified for Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;. FDA reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. FDA action: On June 30, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users 4.1. When using any affected system identified according to the information in section 3, follow the instructions below. 4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is encountered, which may appear in the user interface (UI) with the symbols shown in Figure 4 below: Figure 4. Scan Abort Symbols 4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the message box (see Figure 5 and Figure 6 examples) 4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to expand the message box in case previous messages are hidden, see orange box in Figure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error shown and continue scanning, for example: RF door must be closed while performing scan. Scan aborted. Patient support is moved while scanning, scan stopped. Coil A (or B) failure, coil disconnected? . 4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop scanning immediately and contact Philips Service to describe the problem: If there is no error message in the message box If the error message meaning is not clear 4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row, or if the error message Gradient amplifier Rack Fault is preceded or followed by an aborted scan with no message, then stop scanning immediately and contact Philips Service to describe the problem. 4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt any additional/further scans, including without limitation do not attempt any phantom scanning until your system has been checked... FDA recall Z-1795-2025 is Open, Classified for Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;. FDA reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. FDA action: On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this notice to all users of this device so that they are aware of the issues and associated hazard/harm. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Please complete and return the attached response form to Philips MR promptly and no later than 30 days from receipt of this letter via email to: Philips.Recall@Philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction letter, understanding of the issues, and required actions to be taken. 5. Actions planned by Philips MR to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues (reference FCO78100566, FCO78100584, FCO78100585, FCO78100620, FCO78100621). If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the... FDA recall Z-1798-2025 is Open, Classified for Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;. FDA reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. FDA action: On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this notice to all users of this device so that they are aware of the issues and associated hazard/harm. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Please complete and return the attached response form to Philips MR promptly and no later than 30 days from receipt of this letter via email to: Philips.Recall@Philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction letter, understanding of the issues, and required actions to be taken. 5. Actions planned by Philips MR to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues (reference FCO78100566, FCO78100584, FCO78100585, FCO78100620, FCO78100621). If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event... FDA recall Z-1801-2025 is Open, Classified for Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;. FDA reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. FDA action: On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this notice to all users of this device so that they are aware of the issues and associated hazard/harm. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Please complete and return the attached response form to Philips MR promptly and no later than 30 days from receipt of this letter via email to: Philips.Recall@Philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction letter, understanding of the issues, and required actions to be taken. 5. Actions planned by Philips MR to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues (reference FCO78100566, FCO78100584, FCO78100585, FCO78100620, FCO78100621). If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event... FDA recall Z-1850-2024 is Open, Classified for Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359. FDA reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire FDA action: Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit... FDA recall Z-1851-2024 is Open, Classified for Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356. FDA reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire FDA action: Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the... FDA recall Z-1948-2024 is Open, Classified for HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411. FDA reason: Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard FDA action: Philips NA issued URGENT Medical Device Correction letter to US consigneess dated May 3, 2024 via FedEx. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: A. If you see hydraulic fluid (oil) leakage: " First remove fluid from the floor using a paper towel. Then remove any remaining oil film from the floor using a cleaning agent (e.g. soap and water) and paper towel. " Contact your local Philips service representative. B. You may continue to use your HA FlexTrak Trolley in accordance with the intended use. C. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm until this issue has been resolved. D. Please post this letter near the associated MR system(s) for ease of reference. E. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction, understanding of the issue, and required actions to be taken. A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the HA FlexTrack Trolley and correct if required (reference FCO78100580). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). FDA recall Z-1949-2024 is Open, Classified for HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412. FDA reason: Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard FDA action: Philips NA issued URGENT Medical Device Correction letter to US consigneess dated May 3, 2024 via FedEx. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: A. If you see hydraulic fluid (oil) leakage: " First remove fluid from the floor using a paper towel. Then remove any remaining oil film from the floor using a cleaning agent (e.g. soap and water) and paper towel. " Contact your local Philips service representative. B. You may continue to use your HA FlexTrak Trolley in accordance with the intended use. C. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm until this issue has been resolved. D. Please post this letter near the associated MR system(s) for ease of reference. E. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction, understanding of the issue, and required actions to be taken. A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the HA FlexTrack Trolley and correct if required (reference FCO78100580). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). FDA recall Z-1950-2024 is Open, Classified for HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732. FDA reason: Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard FDA action: Philips NA issued URGENT Medical Device Correction letter to US consigneess dated May 3, 2024 via FedEx. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: A. If you see hydraulic fluid (oil) leakage: " First remove fluid from the floor using a paper towel. Then remove any remaining oil film from the floor using a cleaning agent (e.g. soap and water) and paper towel. " Contact your local Philips service representative. B. You may continue to use your HA FlexTrak Trolley in accordance with the intended use. C. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm until this issue has been resolved. D. Please post this letter near the associated MR system(s) for ease of reference. E. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction, understanding of the issue, and required actions to be taken. A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the HA FlexTrack Trolley and correct if required (reference FCO78100580). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). FDA recall Z-1568-2024 is Open, Classified for Ingenia Ambition S, Magnetic Resonance System.. FDA reason: Patient support table floor plate may be incorrectly installed. FDA action: Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com. FDA recall Z-1569-2024 is Open, Classified for Ingenia Ambition X, Magnetic Resonance System.. FDA reason: Patient support table floor plate may be incorrectly installed. FDA action: Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com. FDA recall Z-1570-2024 is Open, Classified for Ingenia Elition S, Magnetic Resonance System.. FDA reason: Patient support table floor plate may be incorrectly installed. FDA action: Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com. FDA recall Z-1571-2024 is Open, Classified for Ingenia Elition X, Magnetic Resonance System.. FDA reason: Patient support table floor plate may be incorrectly installed. FDA action: Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com. FDA recall Z-2397-2023 is Open, Classified for MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700). FDA reason: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. FDA action: An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A. Post this notice near the affected MR system(s) for ease of reference. Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. Please complete and return the attached updated customer response form to Philips promptly and no later than 30 days from receipt of this letter. Philips is requesting that even if you acknowledged a previous version of this letter that you also respond with an acknowledgment to this updated letter. 4.2. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system (Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier: Remove patient from the system according to the instructions for use because power to the tabletop will still be active Scanning is disabled until Philips service has checked the system. Do not attempt to continue scanning. Immediately inform Philips Service DO NOT attempt to restart or perform a power cycle of the system 4.3. If a user experiences smoke, fire, or severe image quality issues (image artifacts caused by electrical disturbances): Immediately stop scanning and evacuate the patient from the Examination Room. Check Examination Room for a developing fire. If a developing fire is sensed, adhere to established fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by... FDA recall Z-2400-2023 is Open, Classified for MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700). FDA reason: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system. FDA action: An URGENT Medical Device Correction Notice dated 6/5/23 was sent to customers. Actions that should be taken by the customer /user in order to prevent risks for patients or users: 4.1. Philips has installed a SmokeDetector Interlock feature on all the systems listed in Appendix A. Post this notice near the affected MR system(s) for ease of reference. Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm until this issue has been resolved. Please complete and return the attached updated customer response form to Philips promptly and no later than 30 days from receipt of this letter. Philips is requesting that even if you acknowledged a previous version of this letter that you also respond with an acknowledgment to this updated letter. 4.2. The SmokeDetector Interlock feature is integrated with the MR System and powers off the relevant part of the system(Gradient Amplifier) when smoke is detected in order to prevent further development of smoke and/or fire. If the SmokeDetector Interlock has detected smoke and has powered off the Gradient Amplifier: Remove patient from the system according to the instructions for use because power to the tabletop will still be active Scanning is disabled until Philips service has checked the system. Do not attempt to continue scanning. Immediately inform Philips Service DO NOT attempt to restart or perform a power cycle of the system 4.3. If a user experiences smoke, fire, or severe image quality issues (image artifacts caused by electrical disturbances): Immediately stop scanning and evacuate the patient from the Examination Room. Check Examination Room for a developing fire. Ifa developing fire... FDA recall Z-0715-2024 is Open, Classified for (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359). FDA reason: The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.) FDA action: Starting in July 2021, Philips Field Service Engineers (FSE) visited impacted customer sites to inspect the affected systems and turn on the circuit breaker of the extended battery of the UPS where required. All impacted systems were addressed as of February 9, 2023. Instructions for manufacturing and installation were updated on October 31, 2020, which included more detailed instructions for the correct setting of the circuit breaker.

FDA source Exact FDA submission Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

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• Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 31 FDA recall candidates were manually reviewed: 31 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 31 postmarket candidate records; 31 have been reviewed (31 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• K213583 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-1954-2026: Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1955-2026: Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1956-2026: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1960-2026: Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1961-2026: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1966-2026: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1967-2026: Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1968-2026: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1969-2026: Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1204-2026: Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1205-2026: Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1210-2026: Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1215-2026: SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2204-2025: Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2208-2025: Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2209-2025: Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1795-2025: Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1798-2025: Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1801-2025: Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1850-2024: Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1851-2024: Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1948-2024: HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1949-2024: HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1950-2024: HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732 U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1568-2024: Ingenia Ambition S, Magnetic Resonance System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1569-2024: Ingenia Ambition X, Magnetic Resonance System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1570-2024: Ingenia Elition S, Magnetic Resonance System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1571-2024: Ingenia Elition X, Magnetic Resonance System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2397-2023: MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2400-2023: MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700) U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-0715-2024: (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359) U.S. Food and Drug Administration · 2026-09-04
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Philips SmartSpeed AI Philips · 2026-09-03