Philips Ultrasound, LLC 2025-12-10 Health serious FDA
Health · FDA · Recall #FDA-Z-0883-2026
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, Recall
Issued December 10, 2025 · Philips Ultrasound, LLC
In December 2025, Philips Ultrasound, LLC recalled the Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
What you should do
- 1 Stop using Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips Ultrasound, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips Ultrasound, LLC
- Category
- Health
- Recall date
- December 10, 2025
- Units affected
- Not reported
- Sold at
- Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD
- Recall number
- FDA-Z-0883-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips Ultrasound, LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.