FDA Recalls Maquet Anesthesia Devices Over Ventilation Risk

Law360, New York (July 9, 2012, 3:23 PM EDT) -- The U.S. Food and Drug Administration has issued its most urgent recall for Maquet Medical Systems USA anesthesia systems with a glitch that can prevent the devices from switching from manual to automatic ventilation, the company said Friday.

The agency has deemed a voluntary field correction issued by Maquet in February a Class I recall, which is reserved for defective products that pose a significant risk of serious injury or death.

Certain FLOW-i Anesthesia Systems models have a software problem, Maquet said. If the manual-automatic ventilation...
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