| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00242-1 |
| Product Name/Description |
SIGNA Pioneer MRI System
ARTG Number: 252692 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential safety issue with a missing ferrous warning label on the SIGNA Pioneer Table Control Box (TCB).
Ferrous material in the TCB could cause unexpected attraction to the MR system’s high-strength magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field.
There have been no events reported as a result of this issue. Clinical scanning of patients is NOT affected by this safety notification. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products at no cost to the affected customers by applying the ferrous warning label to the TCB. These labels are expected to be available and installed by June 2016. A GE Healthcare representative will contact the affected customers to arrange for the correction. |
| Contact Information |
1800 659 465 - GE National Call Centre |