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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Device Recall Terumo APS 1see related information
Date Initiated by FirmNovember 08, 2006
Date PostedFebruary 01, 2007
Recall Status1 Terminated 3 on June 11, 2007
Recall NumberZ-0381-2007
Recall Event ID 36963
510(K)NumberK022947 
Product Classification extracorporeal circulation - Product Code DTQ
ProductTerumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046.
Code Information 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
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionCustomers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed. All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.
Quantity in Commerce35
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTQ
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