Philips C5-2 Transducer.

FDA device recall Z-2050-2025 · posted 2025-07-02 · Open, Classified

Recall details

Recalling firm

Philips Ultrasound, Inc

Reason for recall

Ultrasound transducer devices were refurbished beyond their useful life.

Action taken

An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.

Root cause

Process control

Status

Open, Classified

Product code

ITX

Quantity affected

5,230 units

Distribution

Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong,

Date initiated

2025-05-28

Date posted

2025-07-02

Location

Reedsville, PA

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