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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS1

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 Class 2 Recall
Terumo APS1
see related information
Date Posted May 29, 2009
Recall Status1 Terminated on July 14, 2009
Recall Number Z-1224-2009
Recall Event ID 44848
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface.
Code Information Serial numbers 0020 through 0980.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees were notified via an Urgent Medical Device Correction: Safety Advisory letter dated 1/12/09 advised of the reason for the correction, potential problems, and provided clinical information should the problem(s) arise. Customers are to review the notice, assure that all users are aware of the notice, and confirm receipt of the communication by completing the attached Customer Response Form and faxing it to the number indicated on the form. Questions or concerns should be directed to Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 951
Distribution Worldwide Distribution -- USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, and Viet Nam.
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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