The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning FLOW-i Anaesthesia System, manufactured by Maquet Cardiovascular LLC.
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
For details, please refer to the FDA websites:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1706-2015&w=06172015&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 June 2015