MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision recall
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic…
Why was MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision recalled?
Indications for use are not cleared or approved for market in the U.S.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic…
- Recalling firm
- Med-Hot Thermal Imaging, Inc.
- Quantity
- 12
- Distribution
- US: AL and NJ - Foreign: Nigeria
- Recall date
- May 17, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)