Kabelsketal, N/A, Germany
Tec Com Gmbh recalls
1 recall recorded since 2018, most recently on 14 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 August 2018
- Terminated
- 20 December 2019
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0362-2020
- 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 treatmen
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.