BEUDAMED
    FDA Recall Terminated

    GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

    Recall: Z-1041-2011 · Initiated January 19, 2011

    Recall

    Recall Number
    Z-1041-2011
    Event Number
    57784
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 19, 2011
    Posted
    March 18, 2011
    Terminated
    May 16, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

    Reason

    During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit).

    Action

    The firm plans to repair the defect or to bring product into compliance. The field action is being implemented to inspect the affected units and if found to be missing the certification label, a certification label will be applied. This will be carried out via a Field Modification Instruction planned to be released in March, 2011 with an estimated completion date of July, 2011.

    Distribution

    Nationwide Distribution

    Quantity

    14