FDAFDA · Food and drugs·Recall number Z-2057-2017
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.
Published May 17, 2017 · Recall initiated: January 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Indications for use are not cleared or approved for market in the U.S.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Med-Hot Thermal Imaging, Inc.
- Distributor
- US: AL and NJ - Foreign: Nigeria
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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