The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a…

Date

Aug. 28, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

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

Distribution pattern

US Distribution in the state of CT.

Quantity

10 Systems

Codes and lots

Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit.

Recall started

April 10, 2013

Device type

System, Tomography, Computed, Emission

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

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.

Recall number

Z-1967-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1967-2013. The agency record governs; check it and the company before acting.