Device Recall MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US: AL and NJ - Foreign: Nigeria
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Med-Hot Thermal Imaging, Inc., 5120 S Florida Ave Ste 301, Lakeland FL 33813-2527
  • Manufacturer Parent Company (2017)
  • Source
    USFDA