| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00885-1 |
| Product Name/Description |
Discovery MR450, MR750 and Optima MR450w MRI System
ARTG Number: 108415 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, MR750 and Optima MR450w product. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users that the system may continue to be used as normal even with the yellow foam protruding from the bore. Patient padding should be used as described in the Operating manuals and cleaning practices described in the Operating manuals should be followed. Patient padding will minimise contact with the foam and users are advised not to attempt to remove the foam. GE Healthcare will be installing a permanent cover over the foam in October 2013. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |