Recall Z-0362-2020 ยท DWJ System, Thermal Regulating
Tec Com Gmbh
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.
| Date | Aug 14, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the state of UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140078 | TECOTHERM NEO (T NEO) Inspiration Healthcare, Ltd., Nov 14, 2014 |