Z-2057-2017 Class II Terminated
FDA device recall Z-2057-2017 was initiated by Med-Hot Thermal Imaging, Inc. on January 14, 2017 and is designated Class II. Reason for recall: Indications for use are not cleared or approved for market in the U.S. The recall status is terminated (terminated August 7, 2019). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- January 14, 2017
- Termination Date
- August 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product 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 for Recall
Indications for use are not cleared or approved for market in the U.S.
Distribution Pattern
US: AL and NJ - Foreign: Nigeria
Code Information
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