BEUDAMED
    FDA Enforcement Class II Terminated

    Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    Recall: Z-1339-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1339-2019
    Event ID
    82730
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2019
    Initiation Date
    April 9, 2019
    Classification Date
    May 15, 2019
    Termination Date
    April 23, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    Reason

    In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.

    Code Info

    Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249 148393 148411 148400 148358 148361 148397 148392 148382 148363 148375 155237 155203 155226 155227 155235 131235

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.

    Quantity

    459 (116 US)