FDA-Device2026-04-01Class IIIMISBRANDING
Philips X3-1 ultrasound transducer recalled for labeling clarification on device lifespan
EXPIRATION DATE ERRORNationwide distribution
Check Philips X3-1 ultrasound transducer labeling
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
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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-1627-2026More Philips Ultrasound, Inc recalls
- FDA-Device2026-04-01Philips S5-2 Ultrasound Transducer recalled for clarification on useful life labeling
- FDA-Device2026-04-01Philips S4-1 Ultrasound Transducer recalled for clarification of useful life labeling
- FDA-Device2026-04-01Philips OMNI II TEE Ultrasound Transducer recalled for useful life labeling clarification
- FDA-Device2026-04-01Philips L17-5 Ultrasound Transducer recalled for labeling clarification on useful life
- FDA-Device2026-04-01Philips Mini Multi TEE Ultrasound Transducer recalled for labeling clarification on useful life
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