FDA-Device2017-05-17Class II
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.
Med-Hot Thermal Imaging, Inc.
Hazard
Indications for use are not cleared or approved for market in the U.S.
Sold states
US: AL and NJ - Foreign: Nigeria
Affected count
12
Manufactured in
5120 S Florida Ave Ste 301, N/A, Lakeland, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2057-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief