Official recall notice
FDA DeviceClass IIINotable
FDA Recall: Philips OMNI II 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
2 units
Product description
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.