| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00924-1 |
| Product Name/Description |
GE 3.0T MR Systems (Full body MRI system):
Discovery MR750w 3.0T,
Discovery MR750 3.0T,
SIGNA PET/MR 3.0T,
SIGNA HDxt 3.0T,
SIGNA HDx 3.0T,
SIGNA HD 3.0T,
SIGNA Excite 3.0T and
SIGNA 3.0T
ARTG Number: 223115 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
GE has recently become aware of a potential safety issue with performing head or neck scans on the affected scanners. The currently displayed Specific Absorption Rate (SAR) values could be lower than the actual SAR in the head and neck as predicted by SAR modelling. The predicted HEAD SAR value from the modelling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
When the system transmits RF power using the whole body RF transmit coil, the SAR value displayed on the system user interface, will be shown as equal to the Whole Body SAR; therefore the SAR delivered to the head could be higher than the displayed SAR value. If patients receive higher than expected radio-frequency (RF) energy absorbed during MR imaging procedures, specifically for patients with MR Conditional implants, then localised deep-tissue heating or thermal injury in the vicinity of implants could occur. There have been no injuries identified as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products. In the interim, for patients with MR conditional head and neck implants, customers are advised to use only the transmit/receive HEAD coil for conducting head and neck scans and to follow the implant’s labelling and instructions strictly. Also, do not scan patients with implants that have been labelled as MR Conditional with HEAD SAR requirements other than the IEC limit for 3.2 W/kg, as stated in the MR operator manual. For all patients, limit the length of scan protocols; specifically, do not scan any patient continuously without any break for longer than 100 minutes. As is the case for all MR imaging, follow Good Clinical Practices. This action has been closed-out on 07/09/2016. |
| Contact Information |
1800 659 465 - GE National Call Centre |