Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Lumify Diagnostic Ultrasound System models : 795005 Recalled by Philips Ultrasound, LLC Due to Ultrasound system compatibility issues with Apple devices running...

Date: October 31, 2025
Company: Philips Ultrasound, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound, LLC directly.

Affected Products

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Quantity: 4,819 systems

Why Was This Recalled?

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Ultrasound, LLC

Philips Ultrasound, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report