Z-0362-2020Class II

TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 -

Name: Z-0362-2020 TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 -
Creator: Tec Com Gmbh
Published: 2018-08-14
License: https://open.fda.gov/license/

Tec Com GmbH / initiated 2018-08-14 / Terminated / root cause: manufacturing process

FDA source

Tec Com Gmbh began a recall of 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... on 2018-08-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0362-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-14
Posted: 2019-11-12
Terminated: 2019-12-20
Recalling firm: Tec Com GmbH
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.
Product code: DWJ System, Thermal Regulating
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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Quantity in commerce: 5 units
Distribution: US Nationwide distribution in the state of UT.
Product codes and lots: Serial Numbers: 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0362-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0362-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-12

Product code DWJ

K140078Class IITecotherm Neo (T Neo)Inspiration Healthcare, Ltd. / cleared 2014-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)