Horsens, Denmark
Brainreader ApS recalls
1 recall recorded since 2018, most recently on 14 December 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 December 2020
- Terminated
- 12 August 2021
- Reason
- The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0934-2021
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.