Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall APS 1

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall APS 1see related information
Date Initiated by FirmJune 30, 2006
Date PostedAugust 22, 2006
Recall Status1 Terminated 3 on June 19, 2008
Recall NumberZ-1405-06
Recall Event ID 34487
Product Classification Perfusion System - Product Code DTQ
ProductTerumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.
Code Information Serial numbers 0020 through 0216.
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 roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.
FDA Determined
Cause 2		Other
ActionThe firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.
Quantity in CommerceRecall Numbers Z-1403-1405-2006 -1,135 systems in the U.S. plus 723 internationally.
DistributionWorldwide-USA, 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 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.
-
-