Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
FDA Recall Z-0602-2007 · Posted 2007-06-30
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Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2005-08-01
Date Terminated2009-08-04
Product Quantity534 of both model numbers
Reason for Recall
The power supply may fail to function due to a defective capacitor. (Note; this device incorporates a redundant separate power supply not affected by this capacitor)
Firm Action
The power supplies were replaced as complaints were received between August 2005 and February 2006. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their units will be corrected when replacement components become available.
Root Cause
Other
Distribution Pattern
Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa.
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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