medical Class II Updated 2021-02-10

Brainreader ApS recalls Neuroreader Medical Image Processing Software - Product Usag

Recalled Product

Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.


Hazard / Issue

The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version 2.4
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →