System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is… — recall Z-1968-2012
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 countries including: Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE),
Reported risk: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
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