FDA recall, , High risk
Philips Lumify Diagnostic Ultrasound System
The Philips Lumify Diagnostic Ultrasound System may not recognize transducer registration, prevent scanning, or have unstable connections.
Summary by Recall Canary from the FDA notice
What happened
Philips Ultrasound, LLC recalled the Philips Lumify Diagnostic Ultrasound System because it may not recognize previous transducer registration, prevent scanning, and require re-registration with Wi-Fi/cellular access, which may be unavailable outside the hospital, or have an unstable connection at the transducer USB cable to tablet/phone that may disconnect. The company began the recall on September 24, 2026, and the FDA added it to the Enforcement Report on October 16, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Lumify Diagnostic Ultrasound System
- UDI-DI
- 00884838122116
- 1.X
- 3.X
- 4.X
- 5.X
- 00884838124141
- 2.X
Recall details
- Company began the recall
- Company
- Philips Ultrasound, LLC
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99878
All recalls from Philips Ultrasound, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
