Med-Hot Thermal Imaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2057-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 14, 2017

Date Posted: May 17, 2017

Recall Number: Z-2057-2017

Event ID: 76622

Reason for Recall:

Indications for use are not cleared or approved for market in the U.S.

Status: Terminated

Product Quantity: 12

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

Distribution Pattern:

US: AL and NJ - Foreign: Nigeria

Voluntary or Mandated:

Voluntary: Firm initiated