Events

Retiro De Equipo (Recall) de Device Recall Hologic 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 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
    68298
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1700-2014
  • Fecha de inicio del evento
    2014-05-13
  • Fecha de publicación del evento
    2014-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127292
  • 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
    Selenia full field digital mammography system defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury.
  • Acción
    Hologic notified customers by letter dated 5/13/14 via certified mail or Federal Express to inform customers of the problem and provide acknowledgement of the notification and confirmation that their systems have been corrected A Dealer notification dated 5/13/14 sent by certified mail or Federal Express 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-00806. On 5/16/14 the firm expanded the recall to an additional units Mammography System M-IV (2 units) and Selenia Mammography Systems (4) by letter dated 5/14/14. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.

Device

Device Recall Hologic Selenia Full Field Digital Mammography System
  • Modelo / Serial
    Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea.
  • Descripción del producto
    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. || The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Dirección del fabricante
    Hologic, Inc., 36 Apple Ridge Rd # 37, Danbury CT 06810-7301
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    USFDA