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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Recall
Terumo APS 1
see related information
Date Posted February 14, 2007
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0432-2007
Recall Event ID 36490
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
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
Manufacturer Reason
for Recall
A 'battery needs service' message may be displayed, or the remaining battery time may incorrectly be reported out as 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 489
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.
Total Product Life Cycle TPLC Device Report

 
1 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.
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