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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 17, 2005
Date Posted March 31, 2005
Recall Status1 Terminated 3 on September 16, 2005
Recall Number Z-0666-05
Recall Event ID 31489
510(K)Number K022947  
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
Code Information Serial numbers 0028 through 0527 and 0700 through 0874.
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 pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
FDA Determined
Cause 2		 Other
Action Recall letters dated 3/17/05 were sent to customers advising them of the problem, the temporary fix, and that software will be upgraded.
Distribution Nationwide, Australia, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malasia, Mexico, Pakistan, South Africa, South Korea, Taiwan, 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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