Z-0934-2021 Class II Terminated
FDA device recall Z-0934-2021 was initiated by Brainreader ApS on December 14, 2020 and is designated Class II. Reason for recall: The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA. The recall status is terminated (terminated August 12, 2021). Affected quantity: 43 sites have had access.
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