Recall Z-0934-2021 ยท LLZ System, Image Processing, Radiological
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.
| Date | Dec 14, 2020 |
| Status | Terminated |
| 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 Rep |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140828 | NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE Brainreader Aps, Feb 4, 2015 |