BEUDAMED
    FDA Recall Terminated

    Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.

    Recall: Z-0138-2009 · Initiated August 11, 2008

    Recall

    Recall Number
    Z-0138-2009
    Event Number
    49426
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 11, 2008
    Posted
    November 4, 2008
    Terminated
    December 21, 2012
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.

    Reason

    Unintended movement of the system table and/or C arm.

    Action

    Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.

    Distribution

    Nationwide.

    Quantity

    66 units