Philips XL14-3 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips is recalling 5,230 XL14-3 ultrasound transducers that were refurbished beyond their useful life. The FDA classified this as a Class II recall; no injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a risk-of-harm product with no reported injuries or illnesses. Transducers refurbished beyond useful life may malfunction, affecting diagnostic accuracy.
Plain-English summary
Philips Ultrasound, Inc. is recalling 5,230 XL14-3 transducers that were refurbished beyond their useful life. Ultrasound transducers are medical devices used in clinical ultrasound systems for diagnostic imaging.
The FDA classified this as a Class II recall. Devices refurbished beyond their useful life may not perform reliably, potentially affecting diagnostic accuracy.
The affected transducers were distributed nationwide in the United States and to 49 additional countries. No injuries or illnesses have been reported.
The recalled product
- Product
- Philips XL14-3 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 989605409251
- UDI: (01)00884838074613(21)B1ZL08
- Serial No. B1ZL08.
Distribution
Distributed nationwide across the United States.
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