GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine i...
FDA Recall #Z-0854-2021 — Class II — December 10, 2020
Product Description
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.
Reason for Recall
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.
Recalling Firm
GE Healthcare, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12 units
Distribution
Worldwide
Code Information
Serial numbers: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, 860Z62031
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated