| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01188-1 |
| Product Name/Description |
Table pallet for use with Discovery NM/CT 670 & Discovery NM630 (Diagnostic full body CT X-ray system)
ARTG Number: 197195 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
At scan set up, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and raises concern over potential detector-patient contact. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing work around instructions to mitigate the issue and will be performing a software upgrade to permanently fix the issue. |
| Contact Information |
1800 659 465 - GE Customer Care Centre |