BEUDAMED
    FDA Recall Terminated

    Mobilett XP, mobile X-ray system, Model number 1818454

    Recall: Z-0749-2007 · Initiated March 21, 2007

    Recall

    Recall Number
    Z-0749-2007
    Event Number
    37698
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 21, 2007
    Posted
    April 19, 2007
    Terminated
    August 7, 2007
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Mobilett XP, mobile X-ray system, Model number 1818454

    Reason

    Mounting bolts for tank fork assembly and collimator flange may become loose.

    Action

    Siemens Service Personnel are visiting each consignee, beginning March 21, 2007, to replace the required mounting bolts and tighten them according to required torque specifications.

    Distribution

    The products were shipped to medical facilities nationwide.

    Quantity

    186 units