| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00454-1 |
| Product Name/Description |
1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant MR Systems (Magnetic Resonance Imaging Systems)
ARTG Number: 108415 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
For ClariView and Screen Save from Gems Visualisation Toolkit Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated with the incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. Patient identifying annotation remains correct. Note that related issues have only been seen on PACS systems manufactured by Intelerad (IntelePACS 4-3-1-P350 and InteleBrowser -4-3-1-P350) at this time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing temporary work around instructions and implementing a software update to correct the issue. |
| Contact Information |
1300 722 229 - GE Healthcare National Service and Support Centre |