MEDHOT MTI 2000 THERMAL IMAGING SYSTEM — Class II medical device recall Z-2057-2017
Terminated recall by Med-Hot Thermal Imaging, Inc., reported 2017-05-17, distributed in AL, NJ. Indications for use are not cleared or approved for market in the U.S.
| Recall number | Z-2057-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Med-Hot Thermal Imaging, Inc., Lakeland, FL, United States |
| Recall initiated | 2017-01-14 |
| Classified | 2017-05-09 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2019-08-07 |
| Distributed | AL, NJ |
| Countries outside the US | NG |
| Quantity | 12 |
| Reason classes | unapproved product |
| Model numbers | A315SC, A615SC |
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 for recall
Indications for use are not cleared or approved for market in the U.S.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2057-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.