FDA Issues Class 1 Recall for Maquet Anesthesia System

The FDA has issued a Class 1 recall for Maquet's C20, C30 and C40 FLOW-i Anesthesia Systems due to a software error, the company announced this week.

There was a defect in the product's Man/Auto switch, which is used for changing between manual and automatic ventilation modes. If the switch is left in an in-between position for longer than five seconds, an alarm may be generated that prevents the system from switching to ventilation mode.

Updates to the affected anesthesia systems, which were distributed between May 2010 and December 2011, will include upgrading the software and providing new user's manuals. Maquet's current product production will not be affected.

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