Home / Recalls / Med-Hot Thermal Imaging, Inc. / Z-2057-2017

Z-2057-2017 Class II Terminated

Recalled by Med-Hot Thermal Imaging, Inc. — Lakeland, FL

Recall Details

Product Type: Devices
Report Date: May 17, 2017
Initiation Date: January 14, 2017
Termination Date: August 7, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12

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.

Reason for Recall

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

Distribution Pattern

US: AL and NJ - Foreign: Nigeria

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