Philips Ultrasound, Inc: Transducer, Ultrasonic, Diagnostic
Summary Philips Ultrasound, Inc. is recalling the L12-5 Ultrasound Transducer nationwide because the labeling needs clarification about how long the device remains safe and effective to use in the field. This is a Class II recall affecting the medical device. The transducer was distributed across all U.S. states.
- Recalling firm
- Philips Ultrasound, Inc
- Product
- Philips L12-5 Ultrasound Transducer
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-09-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9a9a5a2c-b6ff-4b81-aa3f-05bc01b35f80