System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is… — recall Z-1970-2012
U.S. FDA — Device Enforcement · United States · 2012-06-25 · Class II
As described by U.S. FDA — Device Enforcement: System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in th
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Ru
Reported risk: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopu
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