BEUDAMED
    FDA Enforcement Class II Terminated

    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

    Recall: Z-0516-2022 · Reported February 2, 2022

    Enforcement

    Recall Number
    Z-0516-2022
    Event ID
    89260
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 2, 2022
    Initiation Date
    October 12, 2021
    Classification Date
    January 21, 2022
    Termination Date
    April 11, 2024
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

    Reason

    Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

    Code Info

    Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 180056

    Distribution

    US Nationwide distribution.

    Quantity

    72 units