| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01112-1 |
| Product Name/Description |
FlexiView 8800 Mobile C-Arms (Mobile, general-purpose, diagnostic, fluoroscopic x-ray system)
ARTG Number: 92396 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare Surgery has finalised the corrections to remedy the issues communicated to the customers
in 2006 and 2007 (TGA Recall Reference #RN-2007-0077) . Specifically, these corrections will address issues involving system lock-ups,
incorrect image display, system stalls during the boot cycle, and failure of the system to display the air kerma and cumulative air kerma. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue. |
| Contact Information |
1800 659 465 - GE Customer Care Centre |