FDA-Device2021-01-20Class II
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - 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
81 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - 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-0856-2021Don't want to check this manually?
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