BEUDAMED
    FDA Enforcement Class II Terminated

    Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

    Recall: Z-0301-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0301-2022
    Event ID
    88962
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    October 20, 2021
    Classification Date
    November 24, 2021
    Termination Date
    June 18, 2024
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

    Reason

    If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

    Code Info

    Serial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014

    Distribution

    US Nationwide Distribution

    Quantity

    67 units