| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00498-1 |
| Product Name/Description |
Whole-Body MR scanners
Multiple product names, software versions and GTIN's
ARTG's: 223115 & 231238 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met:
1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected,
AND
2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration.
If this occurs, it can result in overheating of an MR conditional implant.
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users may continue to use the MR system by following the instructions outlined in the customer letter.
A GE HealthCare representative will contact all affected customers to arrange for the correction at no cost. |
| Contact Information |
1800 659 465 - GE HealthCare Service |