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U.S. Department of Health and Human Services

Class 2 Device Recall TECOTHERM NEO

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  Class 2 Device Recall TECOTHERM NEO see related information
Date Initiated by Firm August 14, 2018
Create Date November 12, 2019
Recall Status1 Terminated 3 on December 20, 2019
Recall Number Z-0362-2020
Recall Event ID 83707
510(K)Number K140078  
Product Classification System, thermal regulating - Product Code DWJ
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.
Code Information Serial Numbers: 2018/09/07, 2018/10/01, 2018/10/02, 2018/10/03, 2018/10/05
Recalling Firm/
Manufacturer		 Tec Com Gmbh
Eingang B
Am Krummling 1
Kabelsketal Germany
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Quantity in Commerce 5 units
Distribution US Nationwide distribution in the state of UT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = INSPIRATION HEALTHCARE LTD
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