FDA-Device2026-04-01Class IIIMISBRANDING
Philips OMNI II TEE Ultrasound Transducer recalled for useful life labeling clarification
What this means
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
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
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-1623-2026Want us to check the next one for you?
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