FDA-Device2026-04-01Class IIIMISBRANDING
Philips Mini Multi TEE Ultrasound Transducer recalled for labeling clarification on useful life
What this means
Philips is clarifying labeling on certain Mini Multi TEE Ultrasound Transducers to better define when these devices should no longer be used in clinical settings. The affected units may lack clear guidance on their useful lifespan, which could affect safe operation.
- If you operate one of the affected models (989605439241, 989605439242, or 21381A), contact Philips for updated labeling information.
- Review the serial numbers listed in the recall notice to determine if your unit is affected.
- Do not discard the device; await instructions from Philips on next steps.
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
11 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips Mini Multi TEE Ultrasound Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1622-2026Want us to check the next one for you?
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