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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 Recall
Terumo APS 1
see related information
Date Posted February 14, 2007
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0491-2007
Recall Event ID 36496
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Code Information Serial numbers 0030, 0033, 0034, 0036 through 0038, 0041 through 0043, 0045 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165 through 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
Quantity in Commerce 1,951
Distribution Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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