FDA-Device2026-04-01Class IIIMISBRANDING
Philips OMNI II TEE Ultrasound Transducer recalled for useful life labeling clarification
EXPIRATION DATE ERRORNationwide distribution
Check Philips OMNI II TEE transducer useful life label
Philips is clarifying the useful life labeling on certain OMNI II TEE Ultrasound Transducers to ensure healthcare facilities have accurate information about when these devices should be replaced. Two units with specific serial numbers (02P8MV and 02MH3J) were affected and distributed nationwide.
- If you operate a healthcare facility with this device, check if your transducer serial number matches the affected units
- Contact Philips for clarified labeling information and guidance on the device's 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
2 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips OMNI II TEE Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1623-2026More 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 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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