| Date Initiated by Firm | August 12, 2003 |
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| Date Posted | November 18, 2004 |
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| Recall Status1 |
Terminated 3 on September 22, 2005 |
| Recall Number | Z-0209-05 |
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| Recall Event ID |
30352 |
| 510(K)Number | K022947 |
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| 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. |
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| 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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Distribution | United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Japan, Korea, Singapore and United Kingdom. |
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| 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
|
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