| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01213-1 |
| Product Name/Description |
MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer MRI systems running application software version DV25.1
ARTG Number: 252692 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue with the MAGiC imaging application. Images may exhibit novel artefacts on MAGiC T2 FLAIR synthetic reconstructions that may be difficult to recognise without access to conventional T2 FLAIR weighted images. This issue has the potential to lead to misinterpretation of the MAGiC images when making medical diagnosis or treatment decisions. With MAGIC acquisition all contrasts are acquired simultaneously, therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artefacts. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE will be correcting all affected products and providing MAGiC operator documentation Release Notes. In the interim, GE is advising users that they may continue to use MAGiC with the following precautions: Exercise caution when reviewing CSF spaces, its adjacent tissues and the posterior fossa, particularly for cases involving subtle pathology. If in doubt, it is advisable to acquire a conventional 2D or 3D T2 FLAIR series or a MAGIC series in a different orientation for cross-sequence comparison. It is always recommended to pay close attention to patient stabilisation during scanning.
Attention should be given to prior cases as they may be affected by this safety issue. For historical data inquiries, contact GE service for assistance in identifying any affected images. This action has been closed out on 15 June 2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |