| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01349-1 |
| Product Name/Description |
3.0T GE 6-Channel Phased Array Flex Coil
Product Code: M0050SS
ARTG Number: 132706 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury.
To date, there have been no injuries reported as a result of this issue.
This action has been undertaken prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare advised users to discontinue placing coil cables exiting towards the patient's feet. Users can continue to use Mode 1. GE Healthcare have corrected all affected units.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
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