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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 1see related information
Date Initiated by FirmNovember 01, 2005
Date PostedJune 30, 2007
Recall Status1 Terminated 3 on June 23, 2009
Recall NumberZ-0599-2007
Recall Event ID 36399
Product Classification Perfusion System - Product Code DTQ
ProductTerumo 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 0171 may be affected. Serial numbers 0031, 0060, 0105, 0106, 0138, 0142 and 0149 have been corrected and the other serial numbers listed will be corrected.
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		The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.
FDA Determined
Cause 2		Other
ActionFirm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
Quantity in Commerce485 of both model numbers
DistributionWorldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.
Total Product Life CycleTPLC 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.
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