| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00462-1 |
| Product Name/Description |
Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic systems)
CT Scanners:
LightSpeed Ultra (8-slice MDAS)
LightSpeed Plus (4-slice MDAS)
LightSpeed QX/i (4-slice MDAS)
LightSpeed 16 (MDAS Only)
PET/CT Scanners:
Discovery ST
Discovery LS
ARTG Numbers: 96044, 128982 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The Service Procedure describing replacement of a power supply on the rotating side of the gantry specifies the wrong torque for the mounting hardware. Because of this error, the three mounting bolts securing the power supply could be over-torqued if the component is replaced on your system. In the unlikely event that the bolts fail on the CT gantry during operation, it could result in serious bodily injury if the component were to be expelled. There have been no reports of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE has updated the Service Manuals for the affected products to update an incorrect torque value and is advising users to ensure the organisation that services the affected equipment uses the latest version of the Service Manual. The latest version of the Service Manuals can be downloaded from the GE document library. This action has been closed-out on 30/01/2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |