Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
FDA Recall Z-0909-2009 · Posted 2009-02-24
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2008-11-07
Date Terminated2009-07-07
Product Quantity565
Reason for Recall
The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.
Firm Action
An "Urgent Medical Device Correction" letter was sent to consignees on November 7, 2008. The letter described the reason for correction and provided instructions to customers. Terumo Cardiovascular Systems Corporation will replace the power manager boards on the affected devices. Customers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, Dominican Republic, Egypt, 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 and Viet Nam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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