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U.S. Department of Health and Human Services

Class 2 Device Recall MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

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  Class 2 Device Recall MEDHOT MTI 2000 THERMAL IMAGING SYSTEM see related information
Date Initiated by Firm January 14, 2017
Create Date May 09, 2017
Recall Status1 Terminated 3 on August 07, 2019
Recall Number Z-2057-2017
Recall Event ID 76622
510(K)Number K063047  
Product Classification System, telethermographic (adjunctive use) - Product Code LHQ
Product MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
Code Information P/N 18001-EBT-MP-D with FLIR A315 camera P/N 15102-EBT-MP-D wjth FLIR A615 camera TotalVision Software versions 1.6  1.7.1
Recalling Firm/
Manufacturer		 Med-Hot Thermal Imaging, Inc.
5120 S Florida Ave Ste 301
Lakeland FL 33813-2527
For Additional Information Contact Carol Chandler
863-646-1599
Manufacturer Reason
for Recall		 Indications for use are not cleared or approved for market in the U.S.
FDA Determined
Cause 2		 Labeling Change Control
Action Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions.
Quantity in Commerce 12
Distribution US: AL and NJ - Foreign: Nigeria
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 = LHQ and Original Applicant = MEDHOT THERMAL IMAGING, INC.
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