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

  • 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 see related information
Date Initiated by Firm August 12, 2003
Date Posted November 18, 2004
Recall Status1 Terminated 3 on September 22, 2005
Recall Number Z-0209-05
Recall Event ID 30352
510(K)Number K022947  
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.
Code Information All units bearing serial numbers 20 through 109.
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 central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.
FDA Determined
Cause 2		 Other
Action Service representatives were sent a service bulletin dated 8/12/03 instructing them to correct units in the field bearing serial numbers between 20 and 109.
Distribution United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Japan, Korea, Singapore and United Kingdom.
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.
-
-