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U.S. Department of Health and Human Services

Class 3 Device Recall APS 1

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 Class 3 Device Recall APS 1see related information
Date Initiated by FirmOctober 19, 2005
Date PostedJuly 27, 2006
Recall Status1 Terminated 3 on June 19, 2008
Recall NumberZ-1286-06
Recall Event ID 34490
510(K)NumberK022947 
Product Classification heart/lung bypass - Product Code DTQ
ProductTerumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).
Code Information All units using Power Manager software version 1.10 which includes serial numbers 11 through 339.
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		While on battery power, the system may flash a low battery warning even though the battery is adequately charged.
FDA Determined
Cause 2		Other
ActionCustomers were notified via letter dated October 19, 2005 that the Power Manager Software would be upgraded within the next six months. As of 7/7/06 all units within the U.S. have been completed and international units are still in the process of being upgraded.
Quantity in Commerce329
DistributionNationwide and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates.
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.
510(K) Database510(K)s with Product Code = DTQ
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