Device product
OMNI II TEE Transducer Probe
Z-2387-2025
Product summary
- Event
- Event 97217
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 171,322 units
- Official record key
device-enforcement:Z-2387-2025
Official wording
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code information: Model No. N/A; UDI: N/A; Serial No. 02DBYL, 02P8MV, 038CLG.
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.