| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00640-1 |
| Product Name/Description |
Revolution CT (diagnostic x-ray system)
ARTG Number: 156650 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injuries have been reported to date related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to continue to use the Revolution CT system, and ensure the warnings regarding Patient Positioning in the IFU are followed. GE will be correcting all affected systems. This action has been closed-out on 20/02/2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |