The FDA has slapped a Class I label on Maquet Medical Systems' voluntary recall of models of its Flow-i anesthesia systems, as a software problem in the devices could lead to injury and death.
The company launched a voluntary recall in February after discovering that its anesthesia devices shipped between May 2010 and December 2011 had a design flaw in their switches between manual and auto ventilation modes. According to Maquet, if the switch was left between on and off for more than 5 seconds, the system may toggle an alarm that kept it stuck in one mode or the other, requiring it to be restarted.
The dangers of that malfunction led the FDA to label it a Class I, the agency's most serious designation, and MedCity News reported that the glitch led to the machine delivering oxygen at levels lower than its setting. Maquet is responding by updating the software of the affected units and updating their user's manuals, the company said.
Maquet, a subsidiary of Sweden's Getinge Group, specializes in surgery-assisting techs for operating rooms. The company generated nearly $1.7 million in 2011, according to a statement.
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