Reported Nov 20, 2019 · Terminated
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product…
Tec Com GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tec Com Gmbh · Eingang B · Kabelsketal, N/A · N/A
Is this the product you have?
TECOTHERM NEO100-130/200-240 VAC50-60 Hz/ max. 350VAClass ISchutzklasse I IP 20
- UDI04260498580002 -
- Product UsageThe 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 patient, depending on the therapy objective
- Lot codes and dates
- Serial Numbers
2018/09/072018/10/012018/10/022018/10/032018/10/05
- Serial Numbers
- Amount recalled
- 5 units
Where it was sold
- Nationwide
- UT
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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