Tec Com TECOTHERM NEO Thermo-Regulation System Recalled for Faulty Peltier Elements
Tec Com GmbH is recalling five TECOTHERM NEO thermo-regulation systems due to faulty Peltier elements that may fail to maintain temperature control.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tec Com GmbH is recalling five units of the TECOTHERM NEO thermo-regulation system. The recall is being initiated because of the potential installation of faulty Peltier elements within the devices. These systems are designed for controlled cold and heat treatment procedures, providing temperature regulation to patients via a mattress.
The faulty Peltier elements may result in a system failure, meaning the device would no longer be able to guarantee temperature control at full power. The affected units were distributed in the state of Utah. The specific serial numbers for the recalled units are 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, and 2018/10/05.
Healthcare facilities and users should check their inventory for these specific serial numbers. If a unit is affected, it should be removed from service to prevent potential issues with temperature regulation during therapy.
The recalled product
- 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…
- Manufacturer
- Tec Com Gmbh
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Serial Numbers: 2018/09/07
- 2018/10/01
- 2018/10/02
- 2018/10/03
- 2018/10/05
Distribution
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