Official recall notice
FDA DeviceClass IIINotable
FDA Recall: Philips OMNI III TEE Ultrasound Transducer
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Recommended action
What to do
75 units
Product description
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.