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U.S. Department of Health and Human Services

Class 3 Device Recall ASP 1

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  Class 3 Device Recall ASP 1 see related information
Date Initiated by Firm October 19, 2005
Date Posted July 27, 2006
Recall Status1 Terminated 3 on June 19, 2008
Recall Number Z-1287-06
Recall Event ID 34490
510(K)Number K022947  
Product Classification heart/lung bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
Code Information All units using Power Manager software version 1.10, which includes serial numbers 6 through 156.
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
Action Customers 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 Commerce 151
Distribution Nationwide 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 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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