The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Infinia, VG, VG Hawkeye and Helix nuclear medicine systems which are manufactured by GE Healthcare. The affected products are manufactured from 2003-2013 for all infinia nuclear medicine systems; 1996-2003 for VG and VG Hawkeye nuclear medicine systems and1992-1996 (by Elscint Ltd) for Helix nuclear medicine systems.
GE Healthcare 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. At this time, the manufacturer has not been permitted access to the equipment. As a result, the manufacturer has not been able to determine the root cause of this incident.
The manufacturer recommends that qualified service personnel to maintain the equipment and that preventative maintenance procedures are executed according to the schedule provided in customer documentation. Customers are asked to re-review safety chapter sections with appropriate personnel to ensure proper operation of the equipment.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00629-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 June 2013