Brainreader ApS Recall 86995
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.
Brainreader ApS Recall 86995 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0934-2021 |
| Event ID | 86995 |
| Event 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. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 43 sites have had access |
| Recall Reason | The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA. |
| Device Classification | 20210210 |
| Device Code Info | Version 2.4 |
| Center Classification Date | 20210129 |
| Recall Initiation Date | 20201214 |
| Recalling Firm | Brainreader ApS |
| Initial Notification | |
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