CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report
Neuroreader Medical Image Processing recalled by Brainreader ApS
Brainreader ApS is recalling Neuroreader Medical Image Processing, distributed nationwide in the US. The recall was initiated on 14 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0934-2021
- FDA event ID
- 86995
- Recalling firm
- Brainreader ApS, Horsens
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2020
- FDA classified
- 29 Jan 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 14 Dec 2020 | Recall initiated by company | |
| 29 Jan 2021 | Classified by FDA | +46 days |
| 10 Feb 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaCaliforniaDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaMassachusettsMarylandMichiganMinnesotaMissouriNew YorkPennsylvaniaTennesseeTexasUtahVirginiaWashingtonWisconsin
Questions about this recall
Is Neuroreader Medical Image Processing recalled?
Yes. Brainreader ApS recalled Neuroreader Medical Image Processing on 14 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0934-2021.
Why was it recalled?
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Which lots are affected?
Version 2.4
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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