FDA-Device2019-07-24Class II

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

GE Healthcare, LLC
Hazard

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

Sold states
Distribution in the US to Texas. International distribution to France, Greece and Switzerland.
Affected count
2 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

Official notice

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

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