Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 10, 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.
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
Brainreader ApS recalled Neuroreader Medical Image Processing Software - Product Usage: intended to automate the c… — a moderate-severity action.
Neuroreader Medical Image Processing Software - Product Usage: intended to automate the c… was recalled by Brainreader ApS in February 10, 2021. Reason: The Neuroreader has been distributed with a reference normative database that is different from the version …. Check the official notice for the remedy. Verify recall #Z-0934-2021 with the FDA Devices before acting.
The recall
Brainreader ApS issued this moderate-severity FDA Devices recall — The Neuroreader has been distributed with a reference normative database that is different from the version ….
- Moderate
- severity level
- Class II
- classification
- February 10, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0934-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0934-2021) was formally reported on February 10, 2021, with the manufacturer initiating the action on December 14, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Brainreader ApS is listed as the recalling firm, operating out of Horsens. Federal records list the affected scope as 43 sites have had access.
The documented reason for this recall is: The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
43 sites have had access
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0934-2021 |
| Date reported | February 10, 2021 |
| Date initiated | December 14, 2020 |
| Recalling firm | Brainreader ApS |
| Firm location | Horsens |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0934-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0934-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 10, 2021.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.