| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00502-1 |
| Product Name/Description |
GE Revolution CT Computed Tomography X-ray systems
Manufactured from July 2015 to March 2016
ARTG Number: 156650 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware that an out of tolerance torque tool was used on three joints on your Revolution CT system during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artefact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that the scanner can continue to be used. If the X-ray Tube joint loosens, the system would fail internal checks and cause the previous mentioned hazards of beam tracking errors, potential scan aborts and/or image artefacts, requiring immediate action by service to realign the system. Should this occur, stop using the system and call the service team to bring the system back into proper operational status.
GE Healthcare will be correcting all affected products. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |