—#120193

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.).

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit.

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. GE Healthcare has provided field modification instructions (FMI) to update software for the Discovery NM/CT570c hybrid system. The software update will correct the incorrect positioning of the table not prescribed by the operator. The FMI includes: A software upgrade with foreign language support to be installed in the affected models listed above, Labels (FMI label and packing label), Software upgrade workflow procedure with functional verification for all modes of operation, and Certification Report, Postponement of Medical Device Correction, Rejection of Medical Device Correction, or Refusal and/or Location Unknown Documentation. For further questions please call (262) 513-4122.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Distribution in the state of CT.

Timeline

Recall initiated: 2013-04-10
Posted by FDA: 2013-08-20
Terminated: 2014-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.