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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-0433-2007
Product Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
Code Information Serial numbers 0006 through 0066 and 0100 through 0245.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Reason for
Recall		 A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly become zero, even when the battery is fully functional.
Action Consignees were sent a letter dated 11/10/06 informing them of the nature of the issues and that the firm would contact them to schedule a service call to install the software upgrade package. The software upgrade installation began at customers on 10/16/06, prior to issuance of the letter to consignees.
Quantity in Commerce 207
Distribution Worldwide distribution ---- including USA and countries 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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