FDAHealthJuly 3, 2025
Philips Ultrasound, Inc — OMNI II TEE Transducer Probe
⚠️ 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
- July 3, 2025
US Nationwide distribution.
What's affected?
- Product
- OMNI II TEE Transducer Probe
- Lot code
- Model No. N/A; UDI: N/A; Serial No. 02DBYL, 02P8MV, 038CLG.
Additional details
Model No. N/A; UDI: N/A; Serial No. 02DBYL, 02P8MV, 038CLG.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 171,322 units.
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