PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 24, 2019 Initiated: July 2, 2019 #Z-1965-2019

Product Description

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
2 devices
Distribution
Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D. Recalled by GE Healthcare, LLC. Units affected: 2 devices.
Why was this product recalled?
Potential for a transducer mis-alignment in certain transvaginal probes.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1965-2019.