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U.S. Department of Health and Human Services

Class 2 Device Recall Neuroreader Medical Image Processing Software

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  Class 2 Device Recall Neuroreader Medical Image Processing Software see related information
Date Initiated by Firm December 14, 2020
Create Date January 29, 2021
Recall Status1 Terminated 3 on August 12, 2021
Recall Number Z-0934-2021
Recall Event ID 86995
510(K)Number K140828  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Version 2.4
Recalling Firm/
Manufacturer		 Brainreader ApS
Emil Mollers Gade 41
REGION
Horsens Denmark
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = BRAINREADER APS
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