BEUDAMED
    FDA Recall Terminated

    Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging modalities. SecurView DX is intended for selection, display, manipulation, filing and media interchange of multimodality images from a variety of different modality systems. It also interfaces to various image storage and printing devices, using DICOM or similar interface standards. The device used with FDA-cleared monitors may be used by a trained physician for display, manipulation, and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multimodality image.

    Recall: Z-1370-2012 · Initiated February 28, 2012

    Recall

    Recall Number
    Z-1370-2012
    Event Number
    61316
    Firm
    Hologic, Inc.
    FEI Number
    1221300
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 28, 2012
    Posted
    April 5, 2012
    Terminated
    May 7, 2012
    Address
    35 Crosby Dr, Bedford, MA, 01730-1450

    Description

    Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging modalities. SecurView DX is intended for selection, display, manipulation, filing and media interchange of multimodality images from a variety of different modality systems. It also interfaces to various image storage and printing devices, using DICOM or similar interface standards. The device used with FDA-cleared monitors may be used by a trained physician for display, manipulation, and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multimodality image.

    Reason

    SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images

    Action

    Hologic Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides instructions on how to re-review the stored images and correct any annotation defect. A SecurView DX 7.3.0 Confirmation of Notification form was enclosed for customers to complete and return to the firm via fax at 866-652-8674. Contact Hologic's Help Desk at 1-877-371-4372 for questions regarding this notice.

    Distribution

    Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.

    Quantity

    7 units