FDA-Device2026-04-01Class IIIMISBRANDING
Philips L12-5 Ultrasound Transducer recalled for useful life labeling clarification
What this means
Philips is clarifying and updating labeling on certain L12-5 ultrasound transducers to better define their useful life in the field. This affects 40 units distributed nationwide. No injuries have been reported.
- If you own or operate one of the affected transducers (check the serial numbers listed), contact Philips for updated labeling or guidance
- Review the useful life information on your device to ensure it aligns with current labeling standards
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
40 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips L12-5 Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1620-2026Want us to check the next one for you?
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