BEUDAMED
    FDA Enforcement Class II Terminated

    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    Recall: Z-1496-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1496-2020
    Event ID
    85071
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    February 14, 2020
    Classification Date
    March 13, 2020
    Termination Date
    April 20, 2021
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    Reason

    A software issue could potentially cause the stand and table movements to be blocked.

    Code Info

    Serial Numbers 123225 105120 123026 105028 111005 111122 111124 111125 123236 111002 123053 123050 123008 123035 123003 123032 123208 123209 123231 123206 123207 123240 105025 111121 123219 111115 111116 111117 111118 111119 111120 123229 123205 123224 123232 123233 123234 123027 111107 123055 123056 105017 123010 123046 111000 111106 123052 111123 111128 123200 123015 123016 105112 ***Added 3/30/2020*** 123031 123022

    Distribution

    US Nationwide distribuiton.

    Quantity

    1452 worldwide (638 US)