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
- Recall Number
- Z-0934-2021
- Event Number
- 86995
- Firm
- Brainreader ApS Emil Mollers Gade 41 REGION Horsens Denmark
- FEI Number
- 3011657336
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 14, 2020
- Terminated
- August 12, 2021
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.
The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.
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.
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.
43 sites have had access