BEUDAMED
    FDA Enforcement Class II Terminated

    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

    Recall: Z-2775-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2775-2015
    Event ID
    71994
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bayer Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    August 4, 2015
    Classification Date
    September 16, 2015
    Termination Date
    August 17, 2016
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702, United States

    Description

    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

    Reason

    Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position.

    Code Info

    Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH. Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501

    Distribution

    Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.

    Quantity

    71