C8-4v Transducer Probe

FDA device recall Z-2357-2025 · posted 2025-08-22 · Open, Classified

Recall details

Recalling firm

Philips Ultrasound, Inc

Reason for recall

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

Action taken

An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.

Root cause

Device Design

Status

Open, Classified

Product code

IYN

Quantity affected

171,322 units

Distribution

US Nationwide distribution.

Date initiated

2025-07-03

Date posted

2025-08-22

Location

Reedsville, PA

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