FDA-Device2013-08-28Class II
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying s
GE Healthcare, LLC
Hazard
GE Healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a CT standalone exam with the Discovery NM/CT 570c
Sold states
US Distribution in the state of CT.
Affected count
10 Systems
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1967-2013Don't want to check this manually?
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