| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00116-1 |
| Product Name/Description |
Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.
ARTG number: 98099 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue involving the breakage of the steel cable which support the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator. There were no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will inspect, and repair as necessary, all affected systems. A GE Healthcare service representative will contact customers to arrange for this correction. Additionally, the Service Procedure which defines the service interval for periodic cable maintenance and replacement is being updated to require a cable replacement every 15 years, and specify annual inspections of the counterweight guide rail bolt paint marking to confirm tightness of the bolt. This is to ensure the ongoing safe operation of this device. This action has been closed-out on 16/02/2016. |
| Contact Information |
1800 659 465 - National Call Centre |