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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LHQ
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