| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00695-1 |
| Product Name/Description |
Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670
All manufacturing dates
ARTG Number: 200439 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
On Wednesday, June 5, 2013, GE Healthcare became aware of an incident at a VA Medical Centre facility in the United States. According to information available, a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 due to a portion of the system falling onto the patient during the scan. GE Healthcare has since determined that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE recommends that users cease use of their Nuclear Medicine system until GE Healthcare can complete an inspection the affected systems. If an issue with the support mechanism fasteners is found on the affected systems, the GE Field Engineer will coordinate the replacement of impacted parts in the Gantry and ensure that the systems are operating safely. For more details, please see http://www.tga.gov.au/safety/alerts-device-nuclear-medicine-imaging-system-130709.htm . |
| Contact Information |
1800 659 465 - GE National Support Centre |