Recall Z-0152-2027— Philips Ultrasound, LLC

Name: FDA recall Z-0152-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-24

Class I · Ongoing

Class I FDA medical device recall by Philips Ultrasound, LLC, initiated 2026-09-24. It names 2 FDA 510(k) clearances: K242519, K242670. Product: Philips Lumify Diagnostic Ultrasound System. Reason: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay..

Recalling firm: Philips Ultrasound, LLC
Classification: Class I
Status: Ongoing
Initiated: 2026-09-24
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

2 on FDA's record

K242519 — Lumify Diagnostic Ultrasound SystemPhilips Ultrasound·cleared 2025-05-15
K242670 — Lumify Diagnostic Ultrasound SystemPhilips Ultrasound·cleared 2025-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips Lumify Diagnostic Ultrasound System

Reason for recall

Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.

Data sourced from openFDA. This site is unofficial and independent of the FDA.