Events

Recall of Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x

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
    66195
  • Event Risk Class
    Class 2
  • Event Number
    Z-2301-2013
  • Event Initiated Date
    2013-09-06
  • Event Date Posted
    2013-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121704
  • 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
    Full field digital,system,x-ray,mammographic - Product Code MUE
  • Reason
    Software: when the selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images.
  • Action
    Hologic sent an Urgent Medical Device Recall letter dated September 5, 2013, by Certified Mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised how to avoid loss of images until Hologic corrects the problem. A software upgrade to customers who are connected to Hologic Connect who have already been connected remotely and customers who have already been connected via a Service Call will receive notification of the problem and the date the system was remotely corrected notified by Certified Mail. A Dealer notification issued by certified mail to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00072. Selenia software version 5.2 will implement a double safeguard to both guarantee a 28 day retention period, as well as ensure images are removed in a least recently used order. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.

Device

Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x
  • Model / Serial
    Software versions 5.0.x and 5.1.x
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.
  • Product Description
    Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Manufacturer Address
    Hologic, Inc., 36 Apple Ridge Rd # 37, Danbury CT 06810-7301
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA