Class 2 Device Recall Terumo APS1

• Date Initiated by Firm: January 12, 2009
• Date Posted: May 29, 2009
• Recall Status: Terminated on July 14, 2009
• Recall Number: Z-1224-2009
• Recall Event ID: 44848
• 510(K)Number: K022947
• Product Classification: Cardiopulmonary Bypass Heart-Lung Machine Console - 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 MI 48103-9586
• For Additional Information Contact: 800-521-2818
• 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: 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 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.