Device product
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Z-1965-2019
Product summary
- Event
- Event 83271
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 devices
- Official record key
device-enforcement:Z-1965-2019
Official wording
Reason: Potential for a transducer mis-alignment in certain transvaginal probes.
Code information: Model H48701EJ; Serial Number 205375KR9; (UDI Number) 01008406821085531116071121205375KR9. Model KTZ157043-R Serial Number 152323KR2 (UDI Number Not Available)
Distribution pattern: Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Derived failure modes
-
Unknown
Potential for a transducer mis-alignment in certain transvaginal probes.