FDA recall Z-1965-2019

GE Healthcare, LLC · Class II · device

Product

Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

Reason for recall

Potential for a transducer mis-alignment in certain transvaginal probes.

Distribution

Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

Key facts

Status
Terminated
Initiation date
2019-07-02
Report date
2019-07-24
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1965-2019