Lumify Diagnostic Ultrasound System

Evidence summary

The K223771 FDA decision summary describes the mobile Lumify hardware and software-controlled ultrasound system, its labeled acquisition modes and broad applications, and the Expanded B-lines Software Feature. The package requires professional image-quality assessment and clinical judgment and does not establish general diagnostic sensitivity or specificity for the system.

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

2 exact-submission FDA recall records in the 2026-09-02 openFDA snapshot identify K223771. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-0883-2026 is Open, Classified for Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,. FDA reason: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. FDA action: On November 1, 2025, Philips issues an Urgent Medical Device Recall (Correction) Notification to affected consignees. Phillips ask consignees to take the following actions: 1. Utilize an Android based device with your Lumify system. 2. Lightning port devices are not affected and may continue to be used as normal. 3. If you use an 05 based device, do not update your OS device to software version lax. 4. Turn off 05 auto-updates on USB host devices for Lumify by following the below steps: 5. Place this Notice with the documentation of the affected Ultrasound system(s); ensure the notice is in a place likely to be viewed by device operators. 6. Circulate this Notice to all users of the affected device(s) so that they are aware of the issue. 7. Complete the Acknowledgment form indicating you have read and understand the recall. 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 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 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 2 FDA recall candidates were manually reviewed: 2 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 2 postmarket candidate records; 2 have been reviewed (2 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 K223771: 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-0883-2026: Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, 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
• 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 Lumify handheld ultrasound Philips · 2026-09-03
• Exploring New and Next Generation Ultrasound Technologies for Medical Education, Patient Care, and New Indications U.S. National Library of Medicine · 2026-09-03