FDA Device recall Z-2057-2017
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnos…
- FDA Device
- Class II
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class II recall of MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnos… by Med Hot Thermal Imaging, citing indications for use are not cleared or approved for market in the U.S.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2057-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-14 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Med Hot Thermal Imaging |
| Distribution | AL, NJ |
Product
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.
Reason
Indications for use are not cleared or approved for market in the U.S.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2057-2017%22
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