# FDA recall Z-0362-2020

> **Tec Com Gmbh** · Class II · device recall initiated 2018-08-14.

## 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.

## 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

US Nationwide distribution in the state of UT.

## Key facts

- **Recall number:** Z-0362-2020
- **Recalling firm:** Tec Com Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-14
- **Report date:** 2019-11-20
- **Termination date:** 2019-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kabelsketal, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2020

## Citation

> AI Analytics. FDA recall Z-0362-2020. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/Z-0362-2020. Source: US FDA. Licensed CC0.

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