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
|
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
|
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.
|