| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00016-1 |
| Product Name/Description |
Precision RXI X-ray Imaging Systems equipped with LCD Video Monitor
LCD Video Monitor Model Number: 2385123-2
LCD Video Monitor Serial Number: 00000001386MC2
ARTG Number: 99423 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue involving the overhead LCD Video Monitor Suspension. There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and a screw in the absence of the locking-nut. To date, no injury has been reported due to this. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that if inappropriate performance or excessive movement of the monitor is observed to immediately contact GE Healthcare. GE Healthcare is correcting all affected systems. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |