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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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  Class 2 Device Recall Terumo Advanced Perfusion System 1 see related information
Date Initiated by Firm August 28, 2018
Create Date September 25, 2018
Recall Status1 Terminated 3 on April 23, 2020
Recall Number Z-3242-2018
Recall Event ID 80957
510(K)Number K172220  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.

Catalog Number 801763
Code Information Serial Numbers: 0386  1481  1497  1509  1526  1529  1531  1532  1535  1536  1537  1538  1539  1540  1541  1542  1543  1544  1545  1546  1548  1549  1550  1551  1552  1553  1554  1555  1556  1557  1558  1561  1562  1563  1564  1565  1566  1570  1597  1612  1630  1631  1640  1641  1649  1547  1560  1559  1567  Spare Parts:  870509 ASSEMBLY POWER MANAGER POD APS S/N: 03130 , 03308          
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
Manufacturer Reason
for Recall		 Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.
FDA Determined
Cause 2		 Process control
Action Terumo CVS issued letter on 8/2/818 via Fed'X 2 day air to inform users of the problem for the Power Manager boards with unverifiable or out of specification screws, potential hazard and field correction. A Terumo Field Service Representative will contact users to schedule the field correction activities. Terumo CVS Customer Service: 1.800.521.2818, Monday  Friday, 8 a.m.  6 p.m. ET
Quantity in Commerce 47 units
Distribution Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
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 and Original Applicant = Terumo Cardiovascular Systems Corporation
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