FDA Recall
Terminated
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 patient, depending on the therapy objective.
Recall: Z-0362-2020
·
Initiated August 14, 2018
Recall
- Recall Number
- Z-0362-2020
- Event Number
- 83707
- Firm
- Tec Com Gmbh Eingang B Am Krummling 1 Kabelsketal Germany
- FEI Number
- 3011097288
- Product Code
- DWJ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 14, 2018
- Terminated
- December 20, 2019
Description
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 patient, depending on the therapy objective.
Reason
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.
Distribution
US Nationwide distribution in the state of UT.
Quantity
5 units