Medical device recalls Moderate risk

Med-Hot Thermal Imaging product recalled over fire hazard

Recall date
January 14, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Med-Hot Thermal Imaging, Inc. recalls MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use…
Recall number
Z-2057-2017
FDA classification
Class II
Brand / firm
Med-Hot Thermal Imaging, Inc.
Sold / distributed
US: AL and NJ - Foreign: Nigeria

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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