| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00773-1 |
| Product Name/Description |
Discovery MR750w (MRI System)
ARTG Number: 223115 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w.
A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
This issue has been observed in the situation in which a user has routinely used the system for off center imaging with large patients (for example, off center wrist or shoulder exams) with transmit gain set near maximum levels. There have been no reports of injury as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE is advising users to continue to use the system and follow the existing Operator Safety Information for proper patient padding and observation during scanning. If a brown discolouration is seen on the inner surface of the patient bore or if a burning smell is noticed, discontinue scanning. GE will be correcting all affected units.
This action has been closed out on the 26/09/2018. |
| Contact Information |
1800 659 465 - GE National Call Centre |