BEUDAMED
    FDA Recall Terminated

    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

    Recall: Z-1119-2015 · Initiated January 16, 2015

    Recall

    Recall Number
    Z-1119-2015
    Event Number
    70342
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 16, 2015
    Posted
    February 17, 2015
    Terminated
    April 21, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

    Reason

    The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

    Action

    Siemens notified their customer via Customer Safety Advisory Letter AX049/14/S, dated January 16, 2015, and has initiated a fix with Update Instruction AX048/14/S which will be completed by a Siemens service technician. Customers with questions should contact the Customer Care Center at 1-800-888-7436. For questions regarding this recall call 610-219-6300.

    Distribution

    Nationwide Distribution to MI only

    Quantity

    1