RecallDepth

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.

Company
Terumo Cardiovascular Systems Corp
Recall Initiated
August 1, 2005
Posted
June 30, 2007
Terminated
August 4, 2009
Recall Number
Z-0602-2007
Quantity
534 of both model numbers
Firm Location
Ann Arbor, MI

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)

Distribution

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.

Lot / Code Info

Serial numbers 0011 through 0395 may be affected.

Root Cause

Other

Action Taken

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.

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