Product Wiki · Recalls · U.S. FDA — Device Enforcement

GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. — recall Z-0854-2021

U.S. FDA — Device Enforcement · United States · 2020-12-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0854-2021
Date of alert
2020-12-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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