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Class 2 Device Recall Terumo APS 1 |
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Date Initiated by Firm |
February 01, 2005 |
Date Posted |
June 30, 2007 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number |
Z-0930-2007 |
Recall Event ID |
37241 |
510(K)Number |
K022947
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Product Classification |
Perfusion System - 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) base; Model 801764. (Not distributed within the United States). |
Code Information |
Serial numbers 0006 through 0066, 0100 through 0144, 0146, 0147 and 0149 may be affected by this issue. Serial number 0046 have been corrected to date. |
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
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Manufacturer Reason for Recall |
System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.
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FDA Determined Cause 2 |
Other |
Action |
The firm corrected the complaint units at the time of the complaints in 2005. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their system will be corrected when replacement components become available. |
Quantity in Commerce |
416 for both models |
Distribution |
Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore. |
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 and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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