Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Recall date

October 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0883-2026

FDA classification

Class II

Brand / firm

Philips Ultrasound, LLC

Sold / distributed

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, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Arme…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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