BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

    Recall: Z-1904-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1904-2021
    Event ID
    87978
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems Nederlands
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 30, 2021
    Initiation Date
    June 23, 2016
    Classification Date
    June 21, 2021
    Termination Date
    February 8, 2023
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

    Reason

    Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

    Code Info

    Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Date(s) of Distribution: 16-SEP-2014 - 04-MAY-2016. System equipment numbers: 64937259 65862117 63304032 63151474 63250793 63303889 63304149 64140063 63855729 63516113 64077887 66407452 66350303 65342973 63210187 63511276; 66923399 66422060 64085323 61099178 64103799 67936786 66730784 66736708 66628236 63883590 64916638 64927462 65345691 66517161 66403768 63218881 67360962 69856976 65258983 66167983 64778594 61655917 65206981 67874859

    Distribution

    Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.

    Quantity

    42 devices