| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00699-1 |
| Product Name/Description |
GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455)
Affected Product: The following CT Scanners, manufactured from 2003 – 2006:
· LightSpeed Ultra (8-slice MDAS)
· LightSpeed Plus (4-slice MDAS)
· LightSpeed QX/i (4-slice MDAS)
· LightSpeed 16 (MDAS Only)
The following PET CT Scanners, manufactured from 2003 – 2005:
· Discovery ST
· Discovery LS
ARTG Numbers: 96044 and 156649 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware that the Service Procedure used to replace a power supply on the rotating side of the gantry specified the incorrect torque for the mounting hardware. Because of this error, the three mounting bolts securing the power supply could have been over-torqued when the component was replaced on your system.
Plastic deformation of the bolts from over-torqueing could worsen over time and eventually fail. However, all 3 bolts holding the power supply would have to fail for the part to fall. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were to be expelled.
There have been no incidents or injuries reported as a result of this procedure error. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products at no cost to users. This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 659 465 - GE National Call Centre |