| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00265-1 |
| Product Name/Description |
GE MRI Systems
Discovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR355, Twinspeed, Vectra, MR Max,
Signa HDx/HDxt/HDi/ 1.5T HDe/Excite-HD 1.5T & 3T/ Excite 1.5T HD, Echospeed & Highspeed/ 1.5T Infinity TwinSpeed, EchoSpeed Plus & HiSpeed Plus/1.0T Infinity HiSpeed Plus & SmartSpeed/EXCITE 3.0T/ EXCITE 3.0T HD/ Excite 1.5T TwinSpeed & EchoSpeed, HiSpeed & SmartSpeed/ Excite 1.5T/ Excite 3.0T/ Contour/I / OpenSpeed/ Profile /Ovation / PET/MR
ARTG: 223115 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the attention of GE Healthcare Systems that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
It has come to the attention of GE Healthcare that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates that would be absent if a previous version was installed. This action has been closed-out on 05/08/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |