FDAHealthSeptember 5, 2025
Philips Ultrasound, Inc — Philips Mini Multi TEE Ultrasound Transducer
⚠️ To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 5, 2025
US Nationwide distribution.
What's affected?
- Product
- Philips Mini Multi TEE Ultrasound Transducer
- Lot code
- Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.
Additional details
Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 11 units.
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