Medical device manufacturer, Terumo Cardiovascular System (Terumo CVS), has issued an urgent field safety notice concerning CDI Blood Parameter Monitoring System 500 distributed during the period October 2009-May 2011.
During functional testing, Terumo CVS identified a defective integrated circuit on the main circuit board in the CDI Blood Parameter Monitoring System 500. This integrated circuit could potentially cause CDI System 500 not to function after a loss of power, either upon intentional power down or due to an unexpected power outage. In this case, the monitor would display error codes upon restart, and would not be useable. There have been no confirmed complaints from CDI System 500 users on this issue.
According to the local supplier, HK is NOT affected.
If you are in possession of the affected products, please contact your supplier for necessary actions.