Class II — Med-Hot Thermal Imaging, Inc.
| Recalling firm | MED-HOT THERMAL IMAGING, INC |
|---|---|
| Registered facility | MED-HOT THERMAL IMAGING, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Indications for use are not cleared or approved for market in the U.S. |
| 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. |
| Quantity | 12 |
| Distribution | US: AL and NJ - Foreign: Nigeria |
| Initiated | 2017-01-14 |
| Classified | 2017-05-09 |
| Terminated | 2019-08-07 |
| Recall number | Z-2057-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Med-Hot Thermal Imaging, Inc. (Z-2057-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76622/
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