Philips V9-2 Transducer Probe Labeling Recall for Useful Life Definition
Philips Ultrasound is recalling 171,322 units of the V9-2 Transducer Probe distributed nationwide to provide clarification and labeling regarding the product's useful life.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This FDA Class III recall addresses a labeling and documentation issue regarding the definition of product useful life. No injuries, illnesses, or deaths have been reported. Per FDA guidelines, labeling and documentation issues without reported patient harm are classified as Low severity.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of the V9-2 Transducer Probe, an ultrasound transducer device distributed nationwide.
The recall has been issued to provide clarification and labeling that defines the useful life of the ultrasound transducers in field use.
Users of the V9-2 Transducer Probe should consult the updated clarification and labeling information from Philips regarding the product's useful life. For additional information or questions, contact Philips Ultrasound, Inc. directly.
The recalled product
- Product
- V9-2 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling
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. 989605466201
- 989606717071
- 989605492481
- 989605456291
- UDI: (01)00884838088573(21)B3FMNT
- (01)00884838102606(21)B3FLM3
- (01)00884838102606(21)B411GD
- (01)00884838102606(21)F053BY
- (01)00884838102606(21)F0HT0R
- 010088483810260621B3Y0MP
- (01)00884838102606(21)F0KG9X
- (01)00884838088573(21)B3FLWW
- (01)00884838102606(21)F0HT11
- (01)00884838102606(21)F04XCK
- 010088483810260621F0FQZG
- 010088483810260621F0FVH7
- (01)00884838102606(21)F06PQM
- (01)00884838102606(21)F06TGM
- (01)00884838088573(21)B32TQN
- (01)00884838102606(21)F0HJWD
Distribution
Distributed nationwide across the United States.
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