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FDAJanuary 14, 2017device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

med hot thermal imagingmedmed hot

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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