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FDA Initiates Class 1 Recall of FLOW-i Anesthesia System

FDA Initiates Class 1 Recall of FLOW-i Anesthesia System

July 10, 2012 — Maquet Medical Systems USA has issued a global recall of the FLOW-i Anesthesia Systems. The recall is being initiated due to a software problem with the manual/auto switch used in ventilation. The company is taking corrective action by upgrading the system’s software and providing new user’s manuals. The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the device, which 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.”

The following FLOW-i Anesthesia System models are affected:

  • C20
  • C30
  • C40

The products were distributed between May 2010 and December 2011. Newer systems do not have the same defect. The recall will not affect the current production of Maquet anesthesia systems.

The problem is that if the ventilator’s manual/auto switch is held in an intermediate position for more than five seconds, a technical alarm goes off. This alarm does not switch the mode, but instead, keeps the machine in the previous mode until the system is restarted.

Maquet had previously taken action regarding the anesthesia systems in February 2012. The company offered voluntary field correction of the FLOW-i Anesthesia System model number C30 in the United States.

The company is recommending that people affected by this recall contact Technical Support at 1-888-627-8383. Furthermore, any injuries, adverse reactions, or quality problems with the device should be reported to the FDA’s MedWatch Program at www.fda.gov/medwatch.

Do I have a FLOW-i Anesthesia System Lawsuit?

The Schmidt Firm, PLLC is currently accepting FLOW-i anesthesia system induced injury cases in all 50 states. If you or somebody you know has been injured by a defective FLOW-i anesthesia system, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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