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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00629-1
Product Name/Description	Infinia, VG, VG Hawkeye and Helix nuclear medical systems All Infinia nuclear medicine systems, manufactured from 2003-2013 VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003 Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd) Multiple products affected ARTG number: 200439
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/06/2013
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	GE Healthcare (HC) has recently became aware of an incident in the United States, a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 where the equipment fell onto the patient during the scan. GEHC was permitted access to the equipment on 17 June 2013 and investigation is ongoing. As a result, GEHC has not been able to determine the root cause of this incident.
Recall Action	Recall for Product Correction
Recall Action Instructions	GE Healthcare recommends that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to the schedule provided in customer documentation. Customers are asked to review safety chapter sections with appropriate personnel to ensure proper operation of the equipment. GE Healthcare is working in conjunction with the TGA for a complete investigation into the incident and will undertake any further action if required.
Contact Information	1300 722 229- GE National Service and Support Centre