FDA-Device2026-04-01Class IIIMISBRANDING
Philips OMNI III TEE Ultrasound Transducer recalled for labeling clarification on useful life
EXPIRATION DATE ERRORNationwide distribution
Check Philips OMNI III TEE transducer expiration
Philips is clarifying and updating labeling on certain OMNI III TEE ultrasound transducers to better define their useful life in the field. This is a precautionary measure affecting 75 units distributed nationwide.
- Check your device serial number against the recalled list
- Contact Philips or your equipment supplier for updated labeling
- Review the manufacturer's guidance on transducer useful life
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sold states
US Nationwide distribution.
Affected count
75 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips OMNI III TEE Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1624-2026More 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 X3-1 ultrasound transducer recalled for labeling clarification on device lifespan
- 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
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