Health Canada has issued a medical device safety alert concerning Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System, manufactured by GE Medical Systems.
According to the safety alert, the manufacturer performed a field action on GE Healthcare nuclear medicine system due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. As part of this field action, the manufacturer updated the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners.
For details, please visit the following Health Canada website:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/41685r-eng.php
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 10 October 2014