Alerta De Seguridad para Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine systems

Safety alert

2014-02-11

2014-02-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140211a.html

Medical device safety alert: ge healthcare infinia and infinia hawkeye, millennium vg, vg hawkeye and varicam nuclear medicine systems medical device manufacturer, ge healthcare, has issued a field safety notice concerning all configurations of infinia and infinia hawkeye, millennium vg, vg hawkeye and varicam nuclear medicine systems. the manufacturer has recently become aware of a potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. this failure mode has been observed on a single system for a whole body scan, in which the detector moved to the home position and then slowly started drifting inward toward the patient. this generated both a visual and audio alert condition on both the console and the gantry. a potential life-threatening hazardous situation may occur if there is unintended radial detector motion leading to patient contact. the manufacturer advises users to monitor the patient and the system during the entire scan procedure to ensure that there is enough clearance between the patient and the detectors, and to follow the technical advice listed in the field safety notice. a representative from the manufacturer will perform a software upgrade on each affected system. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 february 2014.