| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00001-2 |
| Product Name/Description |
Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
All serial numbers
ARTG Number: 201698 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of a potential safety issue related to the operation of the safety latch holding mechanism for the horizontal arm of the x-ray system. This safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. In order to encounter the hazardous situation where the X-ray tube horizontal arm falls, it would require the following condition to occur simultaneously which is highly unlikely:
1) The counter weight cable system (steel cable or pulley/idler) breaks.
2) The safety mechanism does not engage and hold the Tube–Arm
There have been no incidents or injuries reported as a result of this internally found issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products. In the interim, users are advised to continue to use the system with caution. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |