Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
- Recall Initiated
- September 10, 2007
- Posted
- December 1, 2007
- Terminated
- July 7, 2009
- Recall Number
- Z-0323-2008
- Quantity
- 120
- Firm Location
- Ann Arbor, MI
Reason for Recall
Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.
Distribution
Nationwide.
Lot / Code Info
Serial Numbers 0020 through 0041, 0043, 0044, 0046 through 0060, 0062 through 0091, 0094, 0098, 0118 through 0137, 0139 through 0156, 0159 and 0166 through 0176.
Root Cause
Component change control
Action Taken
Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.
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