Company:Terumo Advanced Perfusion System 1
Date of Enforcement Report:2/7/2007
Class:ll
PRODUCT
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046, Recall # Z-0381-2007
REASON
Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ”connect motor” message to be displayed.
CODE
Serial numbers: 0119, 0123, 0124, 0128, 0135, 0136, 0139, 0140, 0146, 0147, 0148, 0151, 0152, 0157, 0171, 0196, 0197, 0214, 0232, 0241, 0271, 0305, 0310, 0315, 0316, 0318, 0323, 0345, 0346, 0372, 0375, 0376, 0377, 0378 and 0380
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone, fax, email or by visit between November 8, 2006 and November 13, 2006. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide
