| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00103-1 |
| Product Name/Description |
GE Healthcare MRI systems with superconducting magnets
ARTG Number: 223115 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
The MRU (Magnet Rundown Unit) is a critical safety component of the MR system that quenches the magnet (i.e., makes it non-magnetic) in emergency situations, such as those that can occur when a ferrous (metal) object is brought into the magnetic field.
At certain sites, the MRU may not be connected to the magnet. If the MRU is disconnected, the MRU will not function as expected and will not quench the magnet when the button is pressed. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times. Further, there is potential for a patient to sustain injury while trapped against the MR scanner. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare has provided instructions to assist end users to determine if the MRU is properly connected. If the MRU is not connected it is recommended that the MRI is not used and GE Healthcare is contacted immediately.
GE Healthcare will inspect all affected systems and ensure the MRU is properly connected to the magnet. This will be performed by GE Healthcare service representative who will contact affected customers to arrange for this inspection and correction if needed. This action has been closed-out on 1/06/2016. |
| Contact Information |
1800 659 465 - GE National Call Centre |