| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00376-1 |
| Product Name/Description |
Discovery MR450, MR750, MR750w and Optima MR450w products, running software versions DV22.0_V02, DV22.1_V01, DV23.0_V01 (MRI System)
ARTG Number: 193173 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
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. In all cases, patient identifying annotation remains correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing temporary work around instructions and implementing a software update. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |