BEUDAMED
    FDA Recall Open, Classified

    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    Recall: Z-0860-2024 · Initiated December 8, 2023

    Recall

    Recall Number
    Z-0860-2024
    Event Number
    93721
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
    FEI Number
    3002807880
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 8, 2023
    Posted
    January 30, 2024

    Description

    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    Reason

    Loss of connectivity between the FlexArm and the Table due to a software issue.

    Action

    The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 12/08/2023 by certified mail to consignees. Consignees with affected devices are asked to utilize the provided workaround instructions. Additionally, consignees are asked to make all users aware of this recall notification and keep a copy of this notification with system documentation. Getinge Field Service Engineers will be dispatched to the field to install software updates to affected devices. Consignees with any questions can contact the recalling firm by phone at 1-800-722-9377. Consignees are asked to return the provided response form to the recalling firm at [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.

    Quantity

    28 systems (9 US, 1 Canada, 18 ROW)