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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 1 see related information
Date Initiated by Firm October 16, 2006
Date Posting Updated February 14, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0490-2007
Recall Event ID 36496
510(K)Number K022947  
Product Classification Perfusion System - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Code Information Serial numbers 0029, 0031 through 0043, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0068, 0070 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0111, 0113 through 0117, 0120 through 0123, 0125 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0207, 0209, 0211 through 0527, 0700 through 0725, 0727, 0730 through 0878, 0880, 0881, 0883 through 0977, 0981 through 0990, 0992, 0993, 0995 through 1266, 1268 through 1528, 1539 through 1579, 2000 through 2018, 2023, 2025, 2027 through 2057 and 2072 through 2083.
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
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
Other
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 1,399
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 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) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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