FDAFebruary 6, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
What to do
FDA enforcement status: Terminated
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
Recall history
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