Recall Z-2057-2017— Med-Hot Thermal Imaging, Inc.

Name: FDA recall Z-2057-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-14

Class II · Terminated

Class II FDA medical device recall by Med-Hot Thermal Imaging, Inc., initiated 2017-01-14, terminated 2019-08-07. It names one FDA 510(k) clearance: K063047. Product: 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: Indications for use are not cleared or approved for market in the U.S..

Recalling firm: Med-Hot Thermal Imaging, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-14
Terminated: 2019-08-07
Firm location: Lakeland, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K063047 — MEDHOT MTI 2000 THERMAL IMAGING SYSTEMMedhot Thermal Imaging, Inc.·cleared 2006-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.