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Terminated

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.

FDA Recall Z-2057-2017 · Posted None

Recalling FirmMed-Hot Thermal Imaging, Inc.
Recall StatusTerminated
Product CodeLHQ
Date Initiated2017-01-14
Date Terminated2019-08-07
Product Quantity12

Reason for Recall

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

Firm Action

Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions.

Root Cause

Labeling Change Control

Distribution Pattern

US: AL and NJ - Foreign: Nigeria

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063047MEDHOT MTI 2000 THERMAL IMAGING SYSTEMMedhot Thermal Imaging, Inc. · 2006-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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