FDA-Device2021-01-20Class II
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
GE Healthcare, LLC
Hazard
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Sold states
Worldwide
Affected count
7 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0858-2021Don't want to check this manually?
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