Tec Com Gmbh: Medical Device Recall in 2019 - (Recall #: Z-0362-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 14, 2018

Date Posted: November 20, 2019

Recall Number: Z-0362-2020

Event ID: 83707

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.

Status: Terminated

Product Quantity: 5 units

Code Information:

Serial Numbers: 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05

Distribution Pattern:

US Nationwide distribution in the state of UT.

Voluntary or Mandated:

Voluntary: Firm initiated