| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00385-1 |
| Product Name/Description |
Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems)
Multiple System IDs
ARTG Number: 108415 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localised melting of the Endbell. This overheating has occurred only while units were being serviced by GE service engineers during repeated evaluation scanning. However, the issue could also occur in Clinical mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
While in clinical mode, If the operator is notified via user interface message that there are multiple X, Y, or Z gradient distortion faults they should monitor for smoke odours or evidence of overheating. If they detect either a smoke odour or evidence of overheating they should stop scanning immediately, remove the patient and call their GE Healthcare Service Representative. Scanning should not resume until the GE Healthcare service representative has confirmed the MRI scanner is functioning normally. GE Healthcare will correct all affected products. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |