C8-4v Transducer Probe
Recall
- Recall Number
- Z-2358-2025
- Event Number
- 97217
- Firm
- Philips Ultrasound, Inc
- FEI Number
- 2518586
- Product Code
- IYN
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 3, 2025
- Posted
- August 22, 2025
- Address
- 1 Echo Dr, Reedsville, PA, 17084-8603
Description
C8-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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.
US Nationwide distribution.
171,322 units