BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0860-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0860-2024
    Event ID
    93721
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    December 8, 2023
    Classification Date
    January 30, 2024
    Address
    Veenpluis 4-6, Best, N/A, Netherlands

    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.

    Code Info

    (1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1086, 1392, 703615, 1079, 743, 703456, 1248; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 1337, 1249, 1925, 1250, 468, 379, 647, 633, 1534, 887, 1349, 280, 969, 197, 1177, 455, 3, 2611, 2716, 606, 2025;

    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)