Philips c5-1 Ultrasound Transducer Probe Labeling Clarification Recall for Device Useful Life
Philips is recalling the c5-1 Transducer Probe to clarify labeling defining device useful life. The recall affects approximately 171,322 units distributed nationwide.
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 is a Class III medical device recall addressing a documentation and labeling matter without reported adverse events. The recall provides clarification on device useful life, qualifying as a documentation issue per FDA classification standards.
Plain-English summary
Philips Ultrasound, Inc. is recalling the c5-1 Transducer Probe to provide clarification and labeling that defines the useful life of these ultrasound transducers in clinical use. The recall affects approximately 171,322 units distributed nationwide.
Healthcare providers and facilities using these devices should review and implement the updated labeling guidance provided by Philips regarding the useful life of the c5-1 Transducer Probe.
The recalled product
- Product
- c5-1 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- product-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. 989605412042
- 989605438541
- 989605388071
- 989605365003
- 989605365001
- 989605366331
- 989605387852
- 989605365004
- 989605492481
- 989605431531
- 989605412072
- 989606702251
- 989605391092
- 989605353303
- 989605418552
- 989605455171
- 989605412041
- UDI: (01)00884838061491(21)B2JTQ2
- (01)00884838061507(21)B2KPHY
- (01)00884838061613(21)B0TN11
Distribution
Distributed nationwide across the United States.
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