Medical device manufacturer, Draeger Medical, has issued a medical device safety alert concerning its Fabius MRI anaesthesia systems [Part numbers: 9039036 and 9054649].
The manufacturer has become aware of cases where the Fabius MRI or parts of the system were attached by the magnetic field of the MRI.
According to the manufacturer, if the Fabius MRI was positioned too close to the MRI, the magnetic force of the MRI could loosen parts of the Fabius MRI and cause personal injury. There were reported cases that the incidents had happened when the device had been moved through the 40 mTesla area, even it was not in use.
The manufacturer has amended the Instructions for Use, and decided to further improve the affected device by supplying the ventilator door with another lock in addition to the existing locking mechanism.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 June 2015