Software Error Prompts Maquet to Recall FLOW-i Anesthesia Systems
An update has been issued on a medical device with a defect that could potentially compromise the health of anyone using the product.
The update was announced by MAQUET Medical Systems USA, the distributor, and Maquet Critical Care AB, the manufacturer, and concerns their FLOW-i Anesthesia Systems of the C20, C30, and C40 models. These products were available from May 2010 through December of last year.
The recall was necessitated due to a software issue that impedes the ability of these products to switch from manual to automatic ventilation mode and vice versa. Should the user of the device not toggle this switch fully to the on or off position, the device can generate a Technical Alarm TE 613. This occurs when the switch is in between on and off for more than five seconds. When the alarm goes off, it becomes impossible to switch between available ventilation modes, and the only way to correct this is to completely restart the system.
These devices were available across the world. Anyone in the United States who thinks they have been adversely affected by this product is advised to report their situation to the MedWatch program in place from the Food and Drug Administration. The FDA has labeled this as a Class I recall, the most serious form of recall there is.