Philips V6-2 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips Ultrasound recalls approximately 5,230 V6-2 ultrasound transducers that were refurbished beyond their useful life. The devices are distributed nationwide and internationally across more than 50 countries.
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 recall for medical devices refurbished beyond their useful life. The source does not report any hospitalizations, injuries, or deaths. Per the severity rubric, risk-of-harm medical devices without reported injuries are classified as High.
Plain-English summary
Philips Ultrasound, Inc. is recalling the Philips V6-2 Transducer, an ultrasound diagnostic imaging device. Approximately 5,230 affected units are involved in this recall.
The recalled transducers were refurbished beyond their manufacturer's useful life. This condition is the basis for the recall.
The affected devices were distributed throughout the United States and internationally across more than 50 countries.
The recalled product
- Product
- Philips V6-2 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
- refurbished-beyond-lifespan
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 (20)
- Model No. 989605357563
- 989605415042
- 989605437982
- 989605387201
- 989605357561
- UDI: (01)00884838061651(21)B1F8BF
- (01)00884838061798(21)036HF1
- (01)00884838061651(21)B1MB1Y
- (01)00884838061651(21)B1P7X7
- (01)00884838061651(21)B20WDH
- (01)00884838061460(21)B1CYQ2
- (01)00884838061460(21)B0ZP1G
- (01)00884838061460(21)B0GX06
- (01)00884838061460(21)B0T41B
- (01)00884838061651(21)B1RYY9
- (01)00884838061651(21)B20X2D
- (01)00884838061460(21)B1K7CX
- (01)00884838061798(21)036GQH
- (01)00884838061798(21)036QQF
- (01)00884838061798(21)B0K8G6
Distribution
Distributed nationwide across the United States.
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