| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00346-1 |
| Product Name/Description |
Optima MR430s and MSK 1.5T Extreme (MRI System)
Scanner identification numbers between '06 01 2008-001' and '01 13 2013-001' (format "mm dd yyyy-nnn")
ARTG Number: 193173 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The GE Extremity 1.5T MR Scanners use a liquid coolant to protect the gradient coil inside the magnet from heating. If the coolant supply lines are assembled incorrectly, they may leak the liquid onto the floor which may result in a slippery surface and fall hazard. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE is correcting the affected units and is asking users to monitor for leakage until the units are corrected. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |