BEUDAMED
    FDA Recall Terminated

    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems

    Recall: Z-1430-2020 · Initiated August 15, 2019

    Recall

    Recall Number
    Z-1430-2020
    Event Number
    83687
    Firm
    Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France
    FEI Number
    3006543086
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 15, 2019
    Terminated
    June 3, 2021

    Description

    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems

    Reason

    A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely without authentication on certain operating systems. An attacker who successfully exploited this vulnerability could execute arbitrary code on the target system; then install programs; view, change, or delete data; or create new accounts with full user rights. If the vulnerability could be exploited locally, it would lock down the computer.

    Action

    On 08/15/19, Urgent Medical Device Recall notices, dated 08/09/19, were mailed to customers informing them to follow the instructions in the notice to download the patch for their system(s). In addition, customers were asked to share this information with laboratory staff, to retain the notification as part of their laboratory Quality System documentation, and to complete and return the response form. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. The latest information on cybersecurity can be found on the following website: https://www.beckmancoulter.com/en/about-beckman-coulter/product-security/product-security-updates. Customers with additional questions were encouraged to contact the firm via email at website: http://www.beckmancoulter.com. The following number was also provided: (800) 526-3821

    Distribution

    U.S.: NY, AZ, FL, NJ, MA, OH, CA, IL, NC, OK, IN, KY, OR, MI, WI, PA, UT, GA, VA, TX, NE, SD, IA, MN, MD, DE, SC, MT, WV, LA, MO, TN, NM, NV, HI, WA, WY, AL, AR, MS, RI, ID, ME, DC, ND, AK, CO, CT, KS, NH, VT

    Quantity

    6479