Z-0934-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 10, 2021
- Initiation Date
- December 14, 2020
- Termination Date
- August 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 sites have had access
Product Description
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.
Reason for Recall
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Distribution Pattern
US Nationwide distribution including in the states of UT, PA, FL, AL, CA, MN, MD, MO, VA, DC, IL, TX, TN, MI, NY, IN, WA, WI, GA, MA.
Code Information
Version 2.4