FDA-Device2026-04-01Class IIIMISBRANDING
Philips S4-1 Ultrasound Transducer recalled for clarification of useful life labeling
What this means
Philips is recalling certain S4-1 ultrasound transducers to clarify and update labeling that defines how long these devices can be safely used in clinical settings. No injuries have been reported. The recall affects 41 units distributed nationwide.
- If you use a Philips S4-1 ultrasound transducer, check the serial number against the list of affected units
- Contact Philips for updated labeling or guidance on useful life for your specific transducer
- Review the product's useful life information before clinical use
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
41 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips S4-1 Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1625-2026Want us to check the next one for you?
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