| Class 2 Device Recall Discovery NM/CT 570 c | |
Date Initiated by Firm | April 10, 2013 |
Date Posted | August 20, 2013 |
Recall Status1 |
Terminated 3 on January 21, 2014 |
Recall Number | Z-1967-2013 |
Recall Event ID |
65797 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
|
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.). |
Code Information |
Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit. |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | 262-513-4122 |
Manufacturer Reason for Recall | 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 |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | 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. |
Quantity in Commerce | 10 Systems |
Distribution | US Distribution in the state of CT. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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