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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Recall
Terumo APS 1
see related information
Date Posted December 01, 2007
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0323-2008
Recall Event ID 38467
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Code Information Serial Numbers 0020 through 0041, 0043, 0044, 0046 through 0060, 0062 through 0091, 0094, 0098, 0118 through 0137, 0139 through 0156, 0159 and 0166 through 0176.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.
Quantity in Commerce 120
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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