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.
Reported: February 10, 2021 Initiated: December 14, 2020 #Z-0934-2021
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.
Details
- Recalling Firm
- Brainreader ApS
- Units Affected
- 43 sites have had access
- 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.
- Location
- Horsens
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Brainreader ApS. Units affected: 43 sites have had access.
Why was this product recalled? ▼
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0934-2021.
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