BEUDAMED
    FDA Recall Terminated

    MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

    Recall: Z-0265-2016 · Initiated September 24, 2015

    Recall

    Recall Number
    Z-0265-2016
    Event Number
    72406
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 24, 2015
    Terminated
    December 5, 2016
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

    Reason

    Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

    Action

    Siemens sent a Field Safety Notice (XP044/15/S) dated September 24, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

    Distributed in PR and the states of MO, NC, GA, MS, LA, and KY.

    Quantity

    15