BEUDAMED
    FDA Recall Terminated

    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

    Recall: Z-0826-2022 · Initiated January 11, 2022

    Recall

    Recall Number
    Z-0826-2022
    Event Number
    89715
    Firm
    Diagnos Inc
    FEI Number
    3009422347
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    January 11, 2022
    Terminated
    June 18, 2024
    Address
    7005 Taschereau Blvd, Suite 265, Brossard Canada

    Description

    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

    Reason

    Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.

    Action

    On 01/11/22, a recall notice was emailed to the firm's customer who was informed to immediately cease using the affected software. The only version of software cleared for commercialization is CARA v1.2.1. The customer was asked to contact a quality management representative if they had questions or comments at 1-405-678-8882 ext. 235 or [email protected]

    Distribution

    US: CA

    Quantity

    1