C6-2 Transducer Probe
FDA device recall Z-2355-2025 · 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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