BEUDAMED
    FDA Recall Terminated

    Seneographe 2000D Digital Mammography X-Ray System

    Recall: Z-0282-04 · Initiated February 6, 2004

    Recall

    Recall Number
    Z-0282-04
    Event Number
    28191
    Firm
    General Electric Med Systems
    FEI Number
    2126677
    Product Code
    IZH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2004
    Posted
    July 20, 2004
    Terminated
    November 23, 2005
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Seneographe 2000D Digital Mammography X-Ray System

    Reason

    The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.

    Action

    The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.

    Distribution

    Nationwide in the United States