BEUDAMED
    FDA Recall Terminated

    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

    Recall: Z-0614-2018 · Initiated August 22, 2017

    Recall

    Recall Number
    Z-0614-2018
    Event Number
    78963
    Firm
    Siemens Medical Solutions USA, INC
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 22, 2017
    Terminated
    August 21, 2018
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

    Reason

    The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

    Action

    Siemens sent an Urgent- Medical Device Correction letter dated August 22, 2017. Our service organization will contact you shortly to arrange a date to perform this corrective action (A system hardware update will be implemented and all affected DP Transceivers below revision 03 will be updated). Following the system hardware update, the cause is eliminated and a recurrence of the fault is prevented. For further questions, please call (610) 448-6461.

    Distribution

    US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.

    Quantity

    207 worldwide (13 distributed in US)