Philips Ultrasound, Inc: Device Recall

Recall #Z-2365-2025 · 07/03/2025

Class III: Low Risk

Recall Details

Recall Number
Z-2365-2025
Classification
Class III
Product Type
Device
Recalling Firm
Philips Ultrasound, Inc
Status
Ongoing
Date Initiated
07/03/2025
Location
Reedsville, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
171,322 units

Reason for Recall

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

Product Description

C9-5ec Transducer Probe

Distribution Pattern

US Nationwide distribution.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.