FDA Enforcement
Class II
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
·
Reported November 20, 2019
Enforcement
- Recall Number
- Z-0362-2020
- Event ID
- 83707
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tec Com Gmbh
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 20, 2019
- Initiation Date
- August 14, 2018
- Classification Date
- November 12, 2019
- Termination Date
- December 20, 2019
- Address
- Eingang B, Am Krummling 1, Kabelsketal, N/A, N/A, Germany
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.
Code Info
Serial Numbers: 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05
Distribution
US Nationwide distribution in the state of UT.
Quantity
5 units