BEUDAMED
    FDA Recall Open, Classified

    Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

    Recall: Z-0975-2019 · Initiated February 8, 2019

    Recall

    Recall Number
    Z-0975-2019
    Event Number
    82014
    Firm
    Draegar Medical Systems, Inc.
    FEI Number
    3005783425
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 8, 2019
    Address
    6 Tech Dr, Andover, MA, 01810-2434

    Description

    Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

    Reason

    The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

    Action

    On February 8, 2019, the firm, Drager, notified affected customers of the recall via an "Urgent: Medical Device Recall" letter. Customers were informed that the existing software had cybersecurity vulnerabilities and that software version VF10.1 would mitigate these issues. Customers were asked to complete a Customer Acknowledgment and Response Form and return it to Drager via fax 215-372-2940 or email to [email protected]. Your local Draeger Service representative will contact you to schedule an appointment for upgrading your systems software once a compatible version has been released for distribution. If you are aware of any incidents related to this issue or if you have any further questions regarding operation of your patient monitor, please contact Drager Service Technical Support between the hours of 8:00 AM- 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2 again).

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    10699 in total