The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).
The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected.
The system is capable of heating and cooling for a single channel or for both channels.
Device Name / Model Number:
HX2 Temperature Management System (P/N 809810)
Recall Date: Apr 16, 2021
Terumo Cardiovascular Systems Corporation
Recall ID: 87834
Product ID: 187214
Enforcement Date: Jun 9, 2021
Last Published: Jun 4, 2021
Emert Number: Z-1789-2021
Emert Status: Notified