Device product
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.
Z-0362-2020
Product summary
- Firm
- Tec Com Gmbh
- Event
- Event 83707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0362-2020
Official wording
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.
Code information: Serial Numbers: 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05
Distribution pattern: US Nationwide distribution in the state of UT.
Derived failure modes
-
Unknown
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.