Food Recalls (FDA)
MAQUET Initiates Class I Recall of the FLOW-i Anesthesia SystemPublished on Friday, 06 July 2012 11:18
- Category: Food Recalls (FDA)
Recall -- Firm Press Release
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MAQUET Initiates Class I Recall of the FLOW-i Anesthesia System
FOR IMMEDIATE RELEASE - July 6, 2012 - Maquet Critical Care AB and MAQUET Medical Systems USA today issued the following update regarding its voluntary worldwide field correction for its C20, C30 and C40 FLOW-i Anesthesia Systems. The recall was related to a software problem with the MAN/AUTO switch used for changing between manual and automatic ventilation modes. The corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall.
This action only affected FLOW-i Anesthesia Systems distributed between May 2010 and December 2011 and therefore, has no affect on the company's current product production, shipping or distribution processes.
In specific C20, C30 and C40 FLOW-i Anesthesia Systems, if the MAN/AUTO switch was not fully engaged in either an "ON" or "OFF position, but rather was placed in an "in- between position" for more than five seconds, a Technical Alarm TE 613 may have been generated. Activation of the Technical Alarm TE 613 causes the system to remain in the original mode selected and does not switch the ventilation mode. To deactivate the Technical Alarm TE 613, the system must be restarted.
In February 2012, MAQUET Medical Systems, USA and Maquet Critical Care AB initiated a voluntary field correction of FLOW-i Anesthesia System, model number C30, in the US. FLOW-i Anesthesia System model numbers C20, C30 and C40 were affected worldwide.
FDA defines Class I recalls as, "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."
For additional information regarding this closed field correction, please contact the local MAQUET Technical Support Department. For US Technical Support, call 1-888-627-8383 and press option 2, followed by option 1, Monday through Friday from 8:00 am-7:00 pm EST.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
FLOW-i is manufactured by Maquet Critical Care AB and distributed in the US by MAQUET Medical Systems USA.
As a trusted partner for hospitals and clinicians since 1838, MAQUET is a global leader in medical systems that advance surgical interventions, cardiovascular procedures and critical care. MAQUET develops and designs innovative products and therapeutic applications for the operating room, hybrid OR/Cath lab, intensive care unit and patient transport within acute care hospitals, improving outcomes and quality of life for patients.
Cardiovascular specialties include intra-aortic balloon counterpulsation therapy for cardiac assist; coronary artery bypass surgery; aortic and peripheral vascular surgery; and extracorporeal circulation.
The Critical Care portfolio includes market-leading intensive care ventilators and anesthesia machines.
MAQUET also equips Surgical Workplaces with critical infrastructure such as flexible room design for OR and ICU; OR tables; lights and ceiling supply units; and OR integration for image data management.
MAQUET is a subsidiary of the publicly listed Swedish Getinge Group. In 2011, MAQUET generated nearly 1.4 billion Euro which is more than half of the Group's annual revenue of 2.4 billion Euros. The Getinge Group has 13,000 employees worldwide, including around 6,000 MAQUET employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives. For more information please visit www.maquet.com and www.getingegroup.com .
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