Z-1964-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- July 2, 2019
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 devices
Product Description
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Reason for Recall
Potential for a transducer mis-alignment in certain transvaginal probes.
Distribution Pattern
Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Code Information
Model KTZ303987-R - Serial Number (UDI Number): 226914KR0 (01008406821084301118032721226914KR0), 198026KR7 (Not Available), 220616KR7 (01008406821084301117091521220616KR7), 205375KR9 (01008406821085531116071121205375KR9)