Neuroreader Medical Image Processing Software - Product recall
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and…
Why was Neuroreader Medical Image Processing Software - Product recalled?
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 2.4
- Product
- Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and…
- Recalling firm
- Brainreader ApS
- Quantity
- 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.
- Recall date
- February 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)