Reported Feb 10, 2021 · Terminated
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of…
Brainreader ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainreader ApS · Emil Mollers Gade 41 · Horsens · N/A
Is this the product you have?
- Neuroreader Medical Image
- Processing Software - Product Usageintended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images
- Lot codes and dates
- Version 2.4
- Amount recalled
- 43 sites have had access
Where it was sold
Why it was recalled
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Brainreader ApS recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.