FDA Medical Device Recalls (openFDA)
Med-Hot Thermal Imaging, Inc.: 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 number
- Z-2057-2017
- Recalling firm
- Med-Hot Thermal Imaging, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2017-01-14
- Posted
- not on file
- Terminated
- 2019-08-07
- Reason
- Indications for use are not cleared or approved for market in the U.S.
- Root cause
- Labeling Change Control
- Action
- Correct software to eliminate any reference to temperature. Test function and notify users of software update with new user instructions.
- Quantity
- 12
- Distribution
- US: AL and NJ - Foreign: Nigeria
- Lot, serial or model codes
- P/N 18001-EBT-MP-D with FLIR A315 camera P/N 15102-EBT-MP-D wjth FLIR A615 camera TotalVision Software versions 1.6 1.7.1
- 510(k) numbers
- ["K063047"]
- PMA numbers
- not on file
- Product code
- LHQ
- Firm FEI
- 3006033213
- Firm city
- Lakeland
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28