| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00535-1 |
| Product Name/Description |
Drager Fabius MRI Anaesthesia Machine
Serial Number Range: all
ARTG Reference: 104223 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Drager became aware of cases in which the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, the magnetic force of the MRI can loosen parts of the Fabius MRI and cause personal injury. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Drager Medical is updating the Instructions for Use Manual and the device labelling clearly state that the device must only be used in areas where the field intensity is no more than 40 mTesla. Additionally, the ventilator door will be altered to include another lock in addition to the existing locking mechanism. This action has been closed-out on 15/08/2016. |
| Contact Information |
03 9244 7248 Draeger Medical |