Recall Z-2051-2025— Philips Ultrasound, Inc

Name: FDA recall Z-2051-2025
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 2 FDA 510(k) clearances: K043535, K030455. Product: Philips C9-5EC 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

2 on FDA's record

K043535 — HD11 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc.·cleared 2005-01-06
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 C9-5EC 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.