Philips C9-3io Transducer Probe Useful Life Labeling Clarification
Philips Ultrasound is recalling 171,322 units of the C9-3io Transducer Probe to provide clarification and labeling regarding the useful life of the devices. Units were distributed nationwide in the United States.
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 FDA recall with no reported injuries, illnesses, or deaths. The recall addresses a labeling and clarification issue regarding product useful life only, not a safety hazard.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 units of the C9-3io Transducer Probe distributed nationwide in the United States. The U.S. Food and Drug Administration has classified this as a Class III recall.
The recall is being issued to provide clarification and labeling to define the useful life of the ultrasound transducers. This action ensures that labeling clearly communicates the product's operational useful life to healthcare providers and facilities.
The recalled product
- Product
- C9-3io Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device
- 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 (7)
- Model No. 989605395612
- UDI: (01)00884838061538(21)B2CYBN
- (01)00884838061538(21)B0WM4Z
- (01)00884838061538(21)B0WM4P
- Serial No. B2CYBN
- B0WM4Z
- B0WM4P.
Distribution
Distributed nationwide across the United States.
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