BEUDAMED
    FDA Recall Terminated

    ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    Recall: Z-1340-2020 · Initiated January 24, 2020

    Recall

    Recall Number
    Z-1340-2020
    Event Number
    84858
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 24, 2020
    Terminated
    July 10, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    Reason

    Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

    Action

    Siemens issued Urgent Medical Device Correction letter dated January 24, 2020 A via AX064/19/S ( corrective action via AX063/19/S), stating reason for recall, health risk and a corrective action: In the event the robotic stand shows stuttering movements or a squealing noise while initiating movements, do not move the robotic stand and C-arm any longer. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will correct the hardware error by replacing all affected relays and altering the wiring via Update Instruction AX063/19/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented

    Distribution

    US Nationwide distribution.

    Quantity

    96 US