Events

Recall of Device Recall The Selenia Full Field Digital Mammography System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lorad, A 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
    47386
  • Event Risk Class
    Class 3
  • Event Number
    Z-1546-2008
  • Event Initiated Date
    2008-02-28
  • Event Date Posted
    2008-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69385
  • 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
    Marker misalignment: the new software version contained a magnification factor that shows cad markers misaligned with the identified indications. the marked area is misaligned up to 2cm from the indication.
  • Action
    Consignees were notified by an Urgent Recall Notice sent on 3/21/08. The letter informed users that representatives were dispatched to all locations and they have corrected the magnification factor problem. The letter instructed users to re-evaluate any cases read using CAD from the period of installation until the date of system correction. The letter also instructed users that only images read with CAD markers are affected. The letter requests users to return a confirmation of notification. For additional information, contact 1-877-371-4372.

Device

Device Recall The Selenia Full Field Digital Mammography System
  • Model / Serial
    Serial Numbers: 28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345, 28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709, 28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807, 28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014, 28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076, 28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577, 28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339, 28412072602, 29408072073, 28407072007S, 28409030072RF and 28409030077RM.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada and the Republic of Korea.
  • Product Description
    Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810
  • Manufacturer
    Lorad, A Hologic, Inc.

Manufacturer

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