Important Safety Alerts

Health Canada posted a medical device safety alert concerning various Magnetic Resonance Imaging (MRI) systems, manufactured by GE Medical Systems. The affected devices are identified as follow:-

• MSK Extreme - MRI System
• Optima MR430S 1.5T - MRI System
• Signa HDE 1.5T MRI System
• Discovery MR750W 3.0T MRI System
• 1.5T Signa Horizon MRI System
• Signa 1.5T Excite HD Magne - MRI System
• 3.0T Signa HDX MRI System
• 1.5T Signa HDX MRI System
• Discovery MR750 MRI system
• 1.5T Signa Infinity Twinspeed with Excite MRI Syst
• Signa 1.5T Infinity Excite MRI System
• Signa HDXT 1.5T MRI System
• Discovery MR450 1.5T MRI System
• Signa HDI 1.5 T MRI System -16 channel mobile
• Optima MR450W -16CH MRI System
• Optima MR450W -32CH MRI System
• Optima MR450W -GEM MRI System
• Optima MR360 Main Unit

In the affected devices, Magnet Rundown Unit (MRU) may not be connected to the magnet. If the MRU is disconnected, the MRU will not function as expected and will not quench the magnet when the button is pressed. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

For details, please refer to the following Health Canada websites:

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/43153r-eng.php

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/43157r-eng.php

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/43103r-eng.php

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/43165r-eng.php

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 8 January 2015