AI Health Index
Product Change Log

What Changed at Philips Lumify

Every material change AI Health Index has tracked at Philips Lumify: new modules, model and architecture updates, clinical evidence, regulatory status, security certifications, and integration depth. Each entry states what changed, cites its source, and carries our read on what it means for a buyer. The graded assessment of this vendor across all fifteen capability axes sits on its index profile.

Funding rounds, valuations, and awards are not product changes and are not logged here. Acquisitions appear only where there is direct product impact.

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October 2026

P
Philips Lumify
Oct 16, 2026
HighVerified
Regulatory / FDA

FDA classified Philips' correction of the Lumify handheld ultrasound system as a Class I recall, posted 16 October after an early alert on 9 October. A software issue can force the app to register the transducer again, which needs Wi-Fi or cellular service, and the USB cable link between transducer and phone or tablet can drop, leaving clinicians unable to scan. Philips reported eight serious injuries and four deaths as of 29 September and has told customers to use Lumify only where a connection is available, unless backup ultrasound is on hand, while it develops a software fix.

Our read

Class I is FDA's most serious recall category. Teams using Lumify in ambulances, aircraft or field care should check their backup plan now, since those are the settings where a connection is least likely.

Related axis: FDA and Regulatory StatusRegulatory filingView source

What has changed at Philips Lumify recently?

The most recent change AI Health Index logged at Philips Lumify is dated Oct 16, 2026. FDA classified Philips' correction of the Lumify handheld ultrasound system as a Class I recall, posted 16 October after an early alert on 9 October.