BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

    Recall: Z-1895-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1895-2024
    Event ID
    94647
    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
    June 5, 2024
    Initiation Date
    May 16, 2024
    Classification Date
    May 24, 2024
    Address
    Veenpluis 4-6, Best, N/A, Netherlands

    Description

    Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

    Reason

    When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

    Code Info

    Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.

    Distribution

    Domestic: OK International: India, Spain, U.A.E.

    Quantity

    1 unit (US)