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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Terumo APS 1		see related information
Date Posted February 14, 2007
Recall Number Z-0434-2007
Product Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Code Information Serial numbers 0011 through 0039 and 0041 through 0500.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Reason for
Recall		 Pump may stop without an audible tone as a result of quickly clearing the internal pump alarm condition or overpressure alert/alarm condition.
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 489
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.
 
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