Events

Recall of Device Recall MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Med-Hot Thermal Imaging, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76622
  • Event Risk Class
    Class 2
  • Event Number
    Z-2057-2017
  • Event Initiated Date
    2017-01-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153694
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, telethermographic (adjunctive use) - Product Code LHQ
  • Reason
    Indications for use are not cleared or approved for market in the u.S.
  • Action
    Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions.

Device

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
    Radiology Devices
  • 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
    Med-Hot Thermal Imaging, Inc.

Manufacturer

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