FDA-Device2012-11-21Class II
Tested AC Control BD, 120V, X2 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.
Terumo Cardiovascular Systems Corporation
Hazard
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
Sold states
Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
Affected count
15 units
Manufactured in
6200 Jackson Road, Ann Arbor, MI, United States
Products
Tested AC Control BD, 120V, X2 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0279-2013Don't want to check this manually?
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