Device recall
Z-2057-2017: MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body…
FDA device recall · Class II · Med-Hot Thermal Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-2057-2017 |
|---|---|
| Recall event | 76622 |
| 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… |
| Product code | LHQ |
| Recalling firm | Med-Hot Thermal Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2019 |
| 510(k) numbers | K063047 |
| FEI number | 3006033213 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database