FDA Medical Device Recalls (openFDA)
Brainreader ApS: 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.
- Recall number
- Z-0934-2021
- Recalling firm
- Brainreader ApS
- 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.
- Status
- Terminated
- Initiated
- 2020-12-14
- Posted
- not on file
- Terminated
- 2021-08-12
- Reason
- The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
- Root cause
- Under Investigation by firm
- Action
- A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to consignees on 12/14/2020 via a email. The consignee is requested to complete the attached recall acknowledgement form. Since the software is cloud-based, Neuroreader will be upgraded to Version 2.5 effective immediately to reflect the version of the reference normative database cleared by FDA. This correction will be implemented at no cost to the consignee. If the consignee experiences any adverse events or quality problems with the use of this product, they are to report this to FDAs MedWatch Adverse Event Reporting Program and to Brainreader as soon as possible. Distributors who further distributed products subject to this recall are asked to please identify customers immediately and notify them of the product recall using the Recall Notification Letter. The firm requests that the distributor direct their customers to contact the firm directly so that they could implement the correction. Brainreader will correct affected product at no cost. The distributor is also ask to please stop any sales of Neuroreader version 2.4. When version 2.5 is released sales can continue.
- 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.
- Lot, serial or model codes
- Version 2.4
- 510(k) numbers
- ["K140828"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3011657336
- Firm city
- Horsens
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28