Date Initiated by Firm | August 12, 2003 |
Date Posted | November 18, 2004 |
Recall Status1 |
Terminated 3 on September 22, 2005 |
Recall Number | Z-0208-05 |
Recall Event ID |
30352 |
510(K)Number | K022947 |
Product Classification |
Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
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Product | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763. |
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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DTQ
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