BEUDAMED
    FDA Enforcement Class II Terminated

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    Recall: Z-1701-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1701-2014
    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 M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    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: 1800314 7263, 180031472, 18002023051PR

    Distribution

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

    Quantity

    3 units