Events

Retiro De Equipo (Recall) de ATEC 091220 Handpiece

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
    56542
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2285-2010
  • Fecha de inicio del evento
    2010-08-11
  • Fecha de publicación del evento
    2010-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93896
  • 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
    Instrument, biopsy - Product Code KNW
  • Causa
    The firm received a customer complaint that the a device labeled as atec 0912-12 was actually atec 0912-20.
  • Acción
    The firm, Hologic, Inc., sent out "Urgent Medical Device Recall" letters by FedEx on August 11, 2010, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to check their inventories and to quarantine any of the recalled product; if the product was distributed further, identify the users and notify them at once of this product recall; segregate all products from this lot and quarantine them in preparation for return to Hologic, and complete and return the enclosed RECALL RESPONSE FORM by fax at 877-574-3255 or mail. Note: Replacement product cannot be sent until Hologic receives your response form. If you have any questions, please contact Hologic directly at 317-344-7630.

Device

ATEC 091220 Handpiece
  • Modelo / Serial
    316
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including Canada, Belgium, Algeria, Germany, London, Lebanon and Italy.
  • Descripción del producto
    Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. || The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Dirección del fabricante
    Hologic, Inc., 6100 Technology Center Dr, Indianapolis IN 46278-6016
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    USFDA