Company:Terumo Cardiovascular Systems Corp
Date of Enforcement Report 6/10/2009
Class:ll
PRODUCT
Terumo Advanced Perfusion System 1 Central Control Monitor; 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. Recall # Z-1224-2009
REASON
The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp. Ann Arbor, MI, by letter dated January 12, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
951 (502 to U.S. and 449 international)
DISTRIBUTION
Nationwide, 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
