| Class 3 Device Recall Terumo APS 1 | |
Date Initiated by Firm | August 01, 2005 |
Date Posted | June 30, 2007 |
Recall Status1 |
Terminated 3 on August 04, 2009 |
Recall Number | Z-0603-2007 |
Recall Event ID |
37049 |
510(K)Number | K022947 |
Product Classification |
Perfusion System - Product Code DTQ
|
Product | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). |
Code Information |
Serial numbers 0006 through 0066 and 0100 through 0187 may be affected. Serial numbers 0046 and 0160 have been corrected. |
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 power supply may fail to function due to a defective capacitor. (Note; this device incorporates a redundant separate power supply not affected by this capacitor) |
FDA Determined Cause 2 | Other |
Action | The power supplies were replaced as complaints were received between August 2005 and February 2006. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their units will be corrected when replacement components become available. |
Quantity in Commerce | 534 of both model numbers |
Distribution | Worldwide Distribution: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Jordan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore and South Africa. |
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
|
|
|
|