Events

Recall of Device Recall Hologics SecurView DX workstation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61316
  • Event Risk Class
    Class 2
  • Event Number
    Z-1370-2012
  • Event Initiated Date
    2012-02-28
  • Event Date Posted
    2012-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107790
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • 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.

Device

Device Recall Hologics SecurView DX workstation
  • Model / Serial
    software version 7.3.0 S/N:298051183669, 29703060119, 298031083133, 298120882443, 298090882384, 29803070916, 2981070859
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-Distributed in the state of Texas and the countries Belgium, Brazil, and Canada.
  • Product 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.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Manufacturer Address
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA