Med-Hot Thermal Imaging System Recalled for Lack of FDA Clearance
Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MTI 2000 Thermal Imaging System because the indications for use are not cleared or approved for the U.S. market.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths. The hazard is regulatory (lack of clearance) rather than a direct physical injury risk, fitting the Moderate category for low-risk or precautionary issues.
Plain-English summary
Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MEDHOT MTI 2000 Thermal Imaging System. The recalled products include the TotalVision software with the Elevated Body Temperature Screening module, used for medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras (Models A615sc and A315sc). The cameras are private labeled as MAX Basic, MAX 76, and MAX 307.
The recall was initiated because the indications for use are not cleared or approved for market in the United States. The affected units were distributed in Alabama and New Jersey, as well as in Nigeria.
Consumers and healthcare facilities should stop using the affected devices and contact Med-Hot Thermal Imaging, Inc. for further instructions.
The recalled product
- 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…
- Manufacturer
- Med-Hot Thermal Imaging, Inc.
- Category
- Medical Device — Thermal Imaging
- Affected units
- 12
Distribution
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