Devicemaker pulls fever scanner off the market after FDA warning

Certify Global, a company that makes fever scanners, is pulling one of its devices off the market after the FDA warned it hadn't been approved to scan multiple people at once, despite its advertisements, The Washington Post reported. 

The FDA sent a warning letter to the company March 4 saying neither its InfinityX PRO nor SNAP XT PRO HID devices are authorized for multiperson screening. Using the fever scanners on several people at once could lead to an infected person being incorrectly assessed as healthy, the agency said. 

Certify Global had advertised the InfinityX device as having "advanced AI technology" that could reliably measure temperatures in crowded places at a distance of up to 10 feet, the Post reported. 

The FDA also issued a public alert March 4 saying that similar devices from Certify Global and other companies could be used in a way that could lead to "potentially serious public health risks." 

Jasmine Neisser, a spokesperson for Certify Global, told the Post that the company is pulling the InfinityX device temporarily to look into the FDA's concerns. Ms. Neisser added that the SnapXT device is in the process of being FDA approved and is designed to scan one person at a time, though the FDA's warning letter said the device had also been advertised for multiperson scanning. 

Read the full article here

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>