FDA-Device2026-04-01Class IIIMISBRANDING
Philips C9-4 ultrasound transducer recalled for labeling clarification on useful life
What this means
Philips Ultrasound, Inc. is clarifying labeling on the C9-4 ultrasound transducer to better define how long the device remains safe and effective in clinical use. This affects a very limited number of units distributed nationwide.
- Verify your transducer model number matches 989605365021
- Review updated labeling from Philips for guidance on device useful life
- Contact Philips if you have questions about your specific unit
The agency's original wording
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1 unit
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips C9-4 Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1619-2026Want us to check the next one for you?
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