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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 Device Recall Terumo APS 1 see related information
Date Initiated by Firm October 16, 2006
Date Posted February 14, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0433-2007
Recall Event ID 36490
510(K)Number K022947  
Product Classification Perfusion System - Product Code DTQ
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 MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 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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