FDAAugust 14, 2018device
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patien...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and no longer be able to guarantee temperature control at full power.
What to do
FDA enforcement status: Terminated
Brands named
tec comtec
UPCs
04260498580002
Recall history
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