Health Canada — Medical Devices · Canada · 2014-10-09 · Type II
As described by Health Canada — Medical Devices: Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System (2014-09-25)
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Archived by the issuing authority — kept for reference
Reported risk: GE Healthcare 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, GE Healthcare updated the preventative maintenance procedure and schedule and added an additional preventative maintenance check for loose fasteners.
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