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.
FDA Recall Z-1224-2009 · Posted 2009-05-29
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2009-01-12
Date Terminated2009-07-14
Product Quantity951
Reason for Recall
The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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