FDA-Device2026-04-01Class IIIMISBRANDING
Philips X7-2 ultrasound transducers recalled for clarification on useful life labelling
What this means
Philips is clarifying and updating labelling on certain X7-2 ultrasound transducers to better define their useful life in the field. This affects a small number of units distributed nationwide. No injuries have been reported.
- If you operate one of the affected serial numbers (03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9), contact Philips for updated labelling or guidance
- Refer to the updated labelling for proper 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
5 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips X7-2 Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1628-2026Want us to check the next one for you?
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