Drug recall
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module…
FDA recall event 76622 · Class II · Med-Hot Thermal Imaging, Inc.
Key facts
| Event ID | 76622 |
|---|---|
| Recall numbers | Z-2057-2017 |
| Recalling firm | Med-Hot Thermal Imaging, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Indications for use are not cleared or approved for market in the U.S. |
| Initiation date | Jan 14, 2017 |
| Report date | May 17, 2017 |
| Termination date | Aug 7, 2019 |
| City | Lakeland |
| State | FL |
| Country | United States |
| FEI number | 3006033213 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: