Device product
Philips OMNI II TEE Ultrasound Transducer
Z-1623-2026
Product summary
- Event
- Event 97643
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1623-2026
Official wording
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code information: Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.