EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System

Evidence summary

The K201012 FDA decision summary identifies the covered Philips ultrasound systems and QLAB software, their diagnostic ultrasound and fluid-flow applications, supported patient populations, and release-specific labeling. FDA software, image-quality, electrical, EMC, and usability evidence does not provide a single product-wide AI classifier sensitivity or specificity value.

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

5 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K201012. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-2354-2025 is Open, Classified for C5-2 Lumify Transducer Probe. FDA reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. FDA action: An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377. FDA recall Z-2374-2025 is Open, Classified for L12-4 Lumify Transducer Probe. FDA reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. FDA action: An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377. FDA recall Z-2392-2025 is Open, Classified for S4-1 Lumify Transducer Probe. FDA reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. FDA action: An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377. FDA recall Z-0070-2022 is Terminated for Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,. FDA reason: Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power. FDA action: On August 24, 2021, Philips issued "Urgent Medical device Correction" notification to affected consignees. The customer communication was distributed via: USPS Certified Mail In addition to informing consignees about the recall, Philips requested consignees take the following actions: Instructions for how to determine the software version of your Ultrasound system: 1. Power up the system and allow it to complete the boot sequence, 2. Press the Wrench icon on the upper right side of the control panel, 3. Press the Service button on the bottom left corner, 4. Under System Management, Press System Information, 5. The software version is listed in the Software Information Section. 4. Describe the actions that should be taken by the customer / user in order to prevent risks for patients or users A. If this shutdown occurs, Philips recommends that the system be put back on AC power and restarted. The system will be fully functional upon restart. However, restarting the system will not prevent the possibility of the issue reoccurring. B. Please complete and return the attached form to Philips promptly and no later than 30 days from receipt (via email: ultrasound.corrections@philips.com, or fax: 1-833-512-7756). 5. Describe the actions planned by Philips Ultrasound to correct the problem A Philips Field Service Engineer will contact you to schedule a software update to permanently resolve the issue (reference FCO79500550). 6. 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 either online, or by regular mail, or by fax. 7. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further... FDA recall Z-0071-2022 is Terminated for Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,. FDA reason: Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power. FDA action: On August 24, 2021, Philips issued "Urgent Medical device Correction" notification to affected consignees. The customer communication was distributed via: USPS Certified Mail In addition to informing consignees about the recall, Philips requested consignees take the following actions: Instructions for how to determine the software version of your Ultrasound system: 1. Power up the system and allow it to complete the boot sequence, 2. Press the Wrench icon on the upper right side of the control panel, 3. Press the Service button on the bottom left corner, 4. Under System Management, Press System Information, 5. The software version is listed in the Software Information Section. 4. Describe the actions that should be taken by the customer / user in order to prevent risks for patients or users A. If this shutdown occurs, Philips recommends that the system be put back on AC power and restarted. The system will be fully functional upon restart. However, restarting the system will not prevent the possibility of the issue reoccurring. B. Please complete and return the attached form to Philips promptly and no later than 30 days from receipt (via email: ultrasound.corrections@philips.com, or fax: 1-833-512-7756). 5. Describe the actions planned by Philips Ultrasound to correct the problem A Philips Field Service Engineer will contact you to schedule a software update to permanently resolve the issue (reference FCO79500550). 6. 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 either online, or by regular mail, or by fax. 7. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further...

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. 5 FDA recall candidates were manually reviewed: 5 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 5 postmarket candidate records; 5 have been reviewed (5 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 K201012: EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System 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-2354-2025: C5-2 Lumify Transducer Probe U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2374-2025: L12-4 Lumify Transducer Probe U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2392-2025: S4-1 Lumify Transducer Probe U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-0070-2022: Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-0071-2022: Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only, 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 EPIQ ultrasound systems Philips · 2026-09-03
• Philips Lumify handheld ultrasound Philips · 2026-09-03