BEUDAMED
    FDA Enforcement Class II Terminated

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    Recall: Z-1700-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1700-2014
    Event ID
    68298
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    May 13, 2014
    Classification Date
    June 3, 2014
    Termination Date
    August 18, 2014
    Address
    36 Apple Ridge Rd # 37, Danbury, CT, 06810-7301, United States

    Description

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    Reason

    Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury

    Code Info

    Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W

    Distribution

    Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.

    Quantity

    11 units