FDA Recall
Terminated
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.
Recall: Z-2057-2017
·
Initiated January 14, 2017
Recall
- Recall Number
- Z-2057-2017
- Event Number
- 76622
- Firm
- Med-Hot Thermal Imaging, Inc.
- FEI Number
- 3006033213
- Product Code
- LHQ
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- January 14, 2017
- Terminated
- August 7, 2019
- Address
- 5120 S Florida Ave, Ste 301, Lakeland, FL, 33813-2527
Description
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.
Action
Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions.
Distribution
US: AL and NJ - Foreign: Nigeria
Quantity
12