Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls CoolBlue Hyper-Hypothermia System- body hypothermia system
Recalled Product
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Hazard / Issue
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Issued by
FDA
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