Recall Z-2057-2025— Philips Ultrasound, Inc

Name: FDA recall Z-2057-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-28

Class II · Ongoing

Class II FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-05-28. It names one FDA 510(k) clearance: K030455. Product: Philips L9-3 Transducer.. Reason: Ultrasound transducer devices were refurbished beyond their useful life..

Recalling firm: Philips Ultrasound, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-05-28
Firm location: Reedsville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K030455 — BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc.·cleared 2003-03-13

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 L9-3 Transducer.

Reason for recall

Ultrasound transducer devices were refurbished beyond their useful life.

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