| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00721-1 |
| Product Name/Description |
Discovery MR750w
ARTG Number: 223115
(GE Healthcare Australia Pty Ltd - MRI system, full-body, superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
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.
To date, no injury has been reported to GE as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE is advising they will be in contact with users to arrnage for impacted products to be corrected.
In the interim, users may continue to use the system by following the existing Operator Manual 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, please contact the local GE Service Representative.
This action has been closed out on 11/01/2021 |
| Contact Information |
1800 659 465 - GE National Call Centre |