Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0362-2020 — 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,

U.S. FDA — Device Enforcement · Germany · 2018-08-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0362-2020
Date of alert: 2018-08-14
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Tec Com Gmbh
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 04260498580002

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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