BEUDAMED
    FDA Recall Terminated

    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

    Recall: Z-0481-2016 · Initiated October 30, 2015

    Recall

    Recall Number
    Z-0481-2016
    Event Number
    72742
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 30, 2015
    Posted
    December 24, 2015
    Terminated
    March 28, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

    Reason

    Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.

    Action

    Siemens sent an Important Customer Safety Notice dated October 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The issue will be remedied with a hardware update AX025/15/S. The affected bypass module hardware will be exchanged with unaffected production lots to eliminate the problem. For further questions call: (610) 219-6300.

    Distribution

    US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.

    Quantity

    17