| Class 3 Device Recall ASP 1 | |
Date Initiated by Firm | October 19, 2005 |
Date Posted | July 27, 2006 |
Recall Status1 |
Terminated 3 on June 19, 2008 |
Recall Number | Z-1287-06 |
Recall Event ID |
34490 |
510(K)Number | K022947 |
Product Classification |
heart/lung bypass - Product Code DTQ
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Product | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States). |
Code Information |
All units using Power Manager software version 1.10, which includes serial numbers 6 through 156. |
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 | While on battery power, the system may flash a low battery warning even though the battery is adequately charged. |
FDA Determined Cause 2 | Other |
Action | Customers were notified via letter dated October 19, 2005 that the Power Manager Software would be upgraded within the next six months. As of 7/7/06 all units within the U.S. have been completed and international units are still in the process of being upgraded. |
Quantity in Commerce | 151 |
Distribution | Nationwide and worldwide, including Australia, Belgium, Canada, China, Dominican Republic, Egypt, Georgia, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand, Turkey and United Arab Emirates. |
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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