Recall Z-1967-2013— GE Healthcare, LLC

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2013-04-10, terminated 2014-01-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.).. Reason: 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.

Recalling firm

GE Healthcare, LLC

Classification

Class II

Status

Terminated

Initiated

2013-04-10

Terminated

2014-01-21

Firm location

Waukesha, WI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.