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.

Reason: 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

Code information: Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.

Distribution pattern: Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI