| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00834-1 |
| Product Name/Description |
Discovery XR656 Wall Stand System (X-ray system)
Part Numbers: 5374989 and 5397837
Serial numbers: 00000100365HL6, 00000099847HL6, 00000109154HL5, 00000108716HL2, 00000109561HL1, 00000109564HL5
ARTG Number: 167617 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of two FlashPad detector falls due to a broken nylon support hook. A detector fall could result in an injury to a patient or operator. There have been reported incidents of detector falls, but no injuries have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that if they observe either one of the nylon support hooks as broken or loose on the Discovery XR656 wall stand system, immediately stop use and contact their local GE Healthcare Service Representative. If the hooks are not broken, users may continue to use the wall stand system. GE Healthcare is correcting all affected systems by replacing the nylon hooks. This action has been closed-out on 03/06/2016. This action has been closed-out on 03/06/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |