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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.

FDA Recall Z-0362-2020 · Posted None

Recalling FirmTec Com Gmbh
Recall StatusTerminated
Product CodeDWJ
Date Initiated2018-08-14
Date Terminated2019-12-20
Product Quantity5 units

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the state of UT.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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