Z-0362-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- August 14, 2018
- Termination Date
- December 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product 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 for Recall
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 Pattern
US Nationwide distribution in the state of UT.
Code Information
Serial Numbers: 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05