FDA-Device2026-04-01Class IIIMISBRANDING
Philips S5-2 Ultrasound Transducer recalled for clarification on useful life labeling
What this means
Philips Ultrasound, Inc. is providing clarification and updated labeling for the S5-2 Ultrasound Transducer to define its useful life in the field. This affects a limited number of units distributed nationwide.
- Verify your Philips S5-2 transducer serial number (B0C824) against the recall notice
- Contact Philips Ultrasound, Inc. for updated labeling and guidance on useful life
- Review updated documentation before continued use in clinical settings
The agency's original wording
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1 unit
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips S5-2 Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1626-2026Want us to check the next one for you?
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