MR 5300 and MR 7700 R11 MR Systems

Evidence summary

The K223442 FDA decision summary describes the MR 5300 and MR 7700 R11 systems, MR image and spectroscopy outputs, DICOM communication, release-specific software, and verification and validation. It emphasizes that physical-parameter accuracy and interventional MR use require clinical-user validation; it does not establish a general AI diagnostic sensitivity or specificity claim.

FDA source Exact FDA submission Checked 2026-09-03

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

Postmarket safety review

3 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K223442. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-1214-2026 is Open, Classified for Upgrade to MR 7700. Product Code (REF): 782130. 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-2213-2025 is Open, Classified for MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;. 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... FDA recall Z-1804-2025 is Open, Classified for Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;. 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 Reporting program...

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. 3 FDA recall candidates were manually reviewed: 3 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 3 postmarket candidate records; 3 have been reviewed (3 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

• FDA 510(k) decision summary K223442: MR 5300 and MR 7700 R11 MR Systems U.S. Food and Drug Administration · 2026-09-03
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-1214-2026: Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2213-2025: MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-1804-2025: Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; 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 MR 5300 and MR 7700 family context Philips · 2026-09-03