FDA Initiates Class 1 Recall of FLOW-i Anesthesia System

July 10, 2012 — The U.S. Food and Drug Administration (FDA) is announcing a Class I recall of the FLOW-i Anesthesia System, manufactured by Maquet Medical Systems USA. The recall is due a software glitch with the ventilator’s manual/auto switch. Maquet has responded to the problem by voluntarily offering field correction, updating the device’s software, and providing customers with new manuals.

The FLOW-i Anesthesia Systems being recalled include the following models:

• C20
• C30
• C40

The problem is with the manual/auto switch for the ventilator. If an operator keeps the switch in an intermediate position for more than five seconds, Technical Alarm TE 613 may be generated. This alarm causes the system to remain in the original position until the entire anesthesia system is restarted.

Maquet initially took action in February 2012 by offering a voluntary field correction of the C30 FLOW-i Anesthesia System in the U.S. The recall has since been expanded globally, and also includes the C20 and C40 models.

Furthermore, the FDA has issued a Class 1 recall. This is the most serious type of recall, reserved for “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” In the official statement for the recall, the FDA did not mention any reports of injury or death associated with the device.

The affected anesthesia devices were sold from May 2010 through December 2011. Devices that are currently in production do not have the defect and are not part of the recall. The recall will not affect the production of anesthesia systems.

Maquet has set up a hotline for customers who are affected by the recall. Customers are encouraged to contact Technical Support at 1-888-627-8383. Furthermore, Maquet is advising that any injuries, fatalities, adverse reactions, or serious quality issues should be immediately reported to the FDA’s MedWatch adverse event surveillance system, at http://www.fda.gov/medwatch.

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