TECOTHERM NEO — Class II medical device recall Z-0362-2020
Terminated recall by Tec Com Gmbh, reported 2019-11-20, distributed nationwide. The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regul
| Recall number | Z-0362-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tec Com Gmbh, Kabelsketal, N/A, Germany |
| Recall initiated | 2018-08-14 |
| Classified | 2019-11-12 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2019-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 04260498580002 |
| Serial numbers | 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0362-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.