BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    Recall: Z-0807-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0807-2020
    Event ID
    84648
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2020
    Initiation Date
    December 20, 2019
    Classification Date
    January 13, 2020
    Termination Date
    May 1, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    Reason

    The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

    Code Info

    Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244

    Distribution

    US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.

    Quantity

    6