Z-2057-2017Class II

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening...

Name: Z-2057-2017 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening...
Creator: Med-Hot Thermal Imaging, Inc.
Published: 2017-01-14
License: https://open.fda.gov/license/

Med-Hot Thermal Imaging, Inc. / initiated 2017-01-14 / Terminated / root cause: labeling and UDI

FDA source

Med-Hot Thermal Imaging, Inc. began a recall of MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part... on 2017-01-14. FDA classified it as Class II and gives the reason as "Indications for use are not cleared or approved for market in the U.S". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2057-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-14
Posted: 2017-05-09
Terminated: 2019-08-07
Recalling firm: Med-Hot Thermal Imaging, Inc.
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.
Product code: LHQ System, Telethermographic (Adjunctive Use)
Reason for recall: Indications for use are not cleared or approved for market in the U.S.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions.
Quantity in commerce: 12
Distribution: US: AL and NJ - Foreign: Nigeria
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-09

Product code LHQ

K063047Class IMedhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. / cleared 2006-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)