C9-2 Ultrasound Transducer Probe Useful Life Labeling Clarification
Philips Ultrasound recalls 171,322 C9-2 Transducer Probe units to provide clarification and labeling defining the useful life of these medical ultrasound transducers. No illnesses or injuries have been reported.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III device with no reported illnesses or injuries. Recall is for labeling clarification to define product useful life, which is a documentation issue.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of C9-2 Transducer Probes to provide clarification and labeling regarding the useful life of these ultrasound transducers. The affected devices were distributed nationwide in the United States.
The purpose of this recall is to ensure that clear labeling is provided to define the useful life of the transducers during clinical use. No illnesses or injuries related to the devices have been reported.
Healthcare facilities and professionals using C9-2 Transducer Probes should refer to communications from Philips Ultrasound regarding the labeling clarification and useful life guidance for these devices.
The recalled product
- Product
- C9-2 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- mis-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. 989605391092
- 989605438431
- 989605418552
- 989605391091
- 989605412042
- UDI: (01)00884838061507(21)B3G8WQ
- 010088483806150721F0G8PX
- (01)00884838061507(21)B25KL1
- (01)00884838061507(21)B2L2LB
- 010088483806150721F0FWFW
- 010088483806150721F0G0CF
- (01)00884838061507(21)F02CP6
- (01)00884838061507(21)B26BXV
- (01)00884838061507(21)B28G5L
- (01)00884838061507(21)B2FG9B
- (01)00884838061507(21)B3G8M5
- (01)00884838061507(21)F03V2C
- (01)00884838061507(21)F040X0
- (01)00884838061507(21)F0G485
- (01)00884838061507(21)B3NLL9
Distribution
Distributed nationwide across the United States.
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