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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00143-1
Product Name/Description	Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurations ARTG Number: 200439
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	10/02/2014
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	GE Healthcare has 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. A potential life-threatening hazardous situation may occur if there is unintended radial detector motion leading to a patient contact. This failure mode has been observed on a single system for a Whole Body scan, in which 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.
Recall Action	Recall for Product Correction
Recall Action Instructions	GE Healthcare is providing safety instructions to prevent any patient injuries if this failure mode occurs in the field. A GE Healthcare Service representative will perform the required service action (that includes a software update) on each affected system.
Contact Information	1800 659 465 - GE Healthcare National Call Centre