FDA-Device2026-04-01Class IIIMISBRANDING
Philips X3-1 ultrasound transducer recalled for labeling clarification on device lifespan
What this means
Philips is clarifying labeling on certain X3-1 ultrasound transducers to better define their useful lifespan in clinical use. This affects a small number of devices distributed nationwide. No injuries have been reported.
- If you use a Philips X3-1 ultrasound transducer, verify the serial number matches the recall list
- Contact Philips for updated labeling or device guidance
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
17 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips X3-1 Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1627-2026Want us to check the next one for you?
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