FDAHealthSeptember 5, 2025
Philips Ultrasound, Inc — Philips OMNI II 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 OMNI II TEE Ultrasound Transducer
- Lot code
- Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.
Additional details
Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 2 units.
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