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U.S. Department of Health and Human Services

Class 2 Device Recall HX2 Temp Manage SYS 120V

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 Class 2 Recall
HX2 Temp Manage SYS 120V
see related information
Date Posted November 13, 2012
Recall Status1 Terminated on July 11, 2013
Recall Number Z-0278-2013
Recall Event ID 63344
Premarket Notification
510(K) Number
K071521 
Product Classification Controller, Temperature, Cardiopulmonary Bypass - Product Code DWC
Product HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Code Information Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards. Customers with questions were instructed to call 1-800-621-2818. For questions regarding this recall call 734-741-6173.
Quantity in Commerce 19 units
Distribution Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
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 = DWC and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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