Z-0934-2021Class II

Neuroreader Medical Image Processing Software -

Name: Z-0934-2021 Neuroreader Medical Image Processing Software -
Creator: Brainreader ApS
Published: 2020-12-14
License: https://open.fda.gov/license/

Brainreader / initiated 2020-12-14 / Terminated

FDA source

Brainreader ApS began a recall of Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the... on 2020-12-14. FDA classified it as Class II and gives the reason as "The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0934-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Posted: 2021-01-29
Terminated: 2021-08-12
Recalling firm: Brainreader
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
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 in commerce: 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.
Product codes and lots: Version 2.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0934-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-01-29

Product code LLZ

K140828Class IINeuroreader Medical Image Processing SoftwareBrainreader Aps / cleared 2015-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)