Recall Z-2406-2025— Philips Ultrasound, Inc

Name: FDA recall Z-2406-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-03

Class III · Ongoing

Class III FDA medical device recall by Philips Ultrasound, Inc, initiated 2025-07-03. It names one FDA 510(k) clearance: K233545. Product: X11-4t Transducer Probe. Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field..

Recalling firm: Philips Ultrasound, Inc
Classification: Class III
Status: Ongoing
Initiated: 2025-07-03
Firm location: Reedsville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K233545 — EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC·cleared 2023-11-30

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

X11-4t Transducer Probe

Reason for recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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