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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