Philips C9-5EC Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips Ultrasound, Inc. is recalling 5,230 Philips C9-5EC Transducers that were refurbished beyond their useful life, which may compromise device performance and reliability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries, illnesses, or deaths. The hazard is performance degradation from refurbishment beyond useful life, representing a theoretical reliability risk rather than an acute safety threat.
Plain-English summary
Philips Ultrasound, Inc. is recalling 5,230 units of the Philips C9-5EC Transducer, an ultrasound device component used in medical imaging. The transducers were refurbished beyond their useful life, which may compromise their performance and reliability in clinical use.
The affected devices were distributed nationwide throughout the United States and internationally to over 50 countries. The recall encompasses units with serial numbers 03307Y, 02KMNY, 02JC8C, and 02Q6LP.
The recalled product
- Product
- Philips C9-5EC Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-degradation
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 (6)
- Model No.989605440801
- UDI: N/A
- Serial No. 03307Y
- 02KMNY
- 02JC8C
- 02Q6LP.
Distribution
Distributed nationwide across the United States.
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