BEUDAMED
    FDA Recall Terminated

    Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.

    Recall: Z-2468-2008 · Initiated August 5, 2008

    Recall

    Recall Number
    Z-2468-2008
    Event Number
    49377
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 5, 2008
    Posted
    September 29, 2008
    Terminated
    December 21, 2010
    Address
    1230 Shorebire Way P.O. Box 7393, Mountain View, CA, 94043

    Description

    Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.

    Reason

    As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.

    Action

    The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.

    Distribution

    Worldwide

    Quantity

    2541 units