BEUDAMED
    FDA Recall Terminated

    AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems

    Recall: Z-0927-2012 · Initiated January 16, 2012

    Recall

    Recall Number
    Z-0927-2012
    Event Number
    60989
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    January 16, 2012
    Posted
    January 27, 2012
    Terminated
    January 31, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems

    Reason

    There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware installed in the bluetooth interface performing the communication between foot switch and system. This is not a general issue but sporadic as a vendor unsystematical

    Action

    Siemens sent an Urgent Field Safety Notice letter on January 16, 2016, to all affected customers The letter identified the product, problem, potential risk, and actions to be taken. Customers were instructed to immediately pass this information to all those who need to be aware and instruct personnel accordingly. Siemens ask that if the device/equipment is no longer in the customers possession to forward this safety notice to the new owner of the device/equipment.

    Distribution

    Nationwide Distribution (USA) including the states of: CA, CT, FL, GA, HI, IL, IN, KY, ME, MD, MI, MS, MO, NH, NJ, NY, NC, OH, OR, TN, TX, UT, VA, WI and Puerto Rico.

    Quantity

    45