Events

Retiro De Equipo (Recall) de Device Recall The Selenia Full Field Digital Mammography System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Lorad, A Hologic, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    47386
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1546-2008
  • Fecha de inicio del evento
    2008-02-28
  • Fecha de publicación del evento
    2008-05-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69385
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Full field digital, system, x-ray, mammographic - Product Code MUE
  • Causa
    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.
  • Acción
    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
  • Modelo / 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.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Canada and the Republic of Korea.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Lorad, A Hologic, Inc., 36 Apple Ridge Rd, Danbury CT 06810-7301
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    USFDA