Reported May 17, 2017 · Terminated
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use…
Med-Hot Thermal Imaging, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Med-Hot Thermal Imaging, Inc. · 5120 S Florida Ave Ste 301 · Lakeland, FL · 33813-2527
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- Amount recalled
- 12
Where it was sold
Why it was recalled
Indications for use are not cleared or approved for market in the U.S.
This product could cause temporary or reversible health problems — stop using it.
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