BEUDAMED
    FDA Recall Terminated

    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

    Recall: Z-2320-2019 · Initiated July 10, 2019

    Recall

    Recall Number
    Z-2320-2019
    Event Number
    83312
    Firm
    Radiometer America Inc
    FEI Number
    3010420736
    Product Code
    CEM
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 10, 2019
    Posted
    August 22, 2019
    Terminated
    June 13, 2022
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

    Reason

    Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

    Action

    On (date), the firm will email a "Urgent Field Safety Notice" to all customers and will follow-up by mailing a copy of the "Urgent Field Safety Notice" to all customers via Federal Express with tracking and proof of delivery. The Urgent Field Safety Notice ask customers to do the following: 1. Check which version of the operating system (OS) is currently installed on your analyzer: o Logon to the analyzer o Touch Menu, Utilities, Temporary shutdown, and then Confirm o During the shutdown process the analyzer displays the version of OS installed " If the OS version is one of the following your analyzer is affected by the vulnerability: RXPE - UIM2743 v1.3.xxxxxx or RXPE-UIM910v1.3.xxxxxx 2. If your analyzer is found to be affected by the vulnerability the following options must be applied: Short term: If your analyzer is connected to a network and your IT department assesses that the Hospital Firewall and Network settings prevent a remote attacker from connecting to the analyzer to exploit the vulnerability, you may decide to keep the analyzer connected. Otherwise, we recommend disconnecting it until one of the long term countermeasures below has been implemented. Long term: Countermeasure 1: Contact your Radiometer representative to have the RXPE Security patch update installed on your analyzer. (Note: Microsoft does not support Windows XP anymore. However, Microsoft has extraordinarily released a patch for this particular vulnerability.) or Countermeasure 2: Contact your Radiometer representative to receive a quote for an upgrade to latest OS (Windows 7 embedded) from Radiometer, which is supported by Microsoft. 3.Please complete the Recall Response Form (last page of the customer advisory letter) and return it to your Radiometer representative. 4.Please Note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. If you have questions, please contact Radiometer

    Distribution

    US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico

    Quantity

    13,042 units