Recall Z-2057-2017 ยท LHQ System, Telethermographic (Adjunctive Use)
Med-Hot Thermal Imaging, Inc.
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.
| Date | Jan 14, 2017 |
| Status | Terminated |
| Reason | Indications for use are not cleared or approved for market in the U.S. |
| Root cause | Labeling Change Control |
| Action | Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions. |
| Quantity | 12 |
| Distribution | US: AL and NJ - Foreign: Nigeria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063047 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM Medhot Thermal Imaging, Inc., Oct 19, 2006 |