FDA-Device2019-07-24Class II

Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

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
3 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2019

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