| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00464-2 |
| Product Name/Description |
Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)
ARTG Number: 108415 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue with the patient table cradle emergency release handle and cradle release block mechanism of certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make difficult the safe removal of the patient from the system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products. Before continued use prior to repair, GE is advising that the operator should assess patient positioning and ease of egress and cease use if cradle movement for egress is impeded. If the operator encounters difficulty in moving the cradle out because the cradle release handle does not release properly or if the cradle movement is impeded, the facility’s GE Healthcare Service Representative should be contacted so that the cradle can be inspected and necessary repairs can be made as soon as possible. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |