The Recall Desk

Manufacturer

Brainreader ApS

1 recall in our database name Brainreader ApS as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-02-10

Of the 1 recalls from Brainreader ApS we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-0934-2021·2021-02-10

    Brainreader Recalls Neuroreader Software Due to Database Discrepancy

    Brainreader ApS is recalling Neuroreader Medical Image Processing Software Version 2.4 because it was distributed with a reference database different from the FDA-cleared version.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide