Events

Retiro De Equipo (Recall) de ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hologic Australia Pty Ltd.

¿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
    RC-2016-RN-01040-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01040-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Hologic have identified that the lid of the atec canister may have cracks that are related to lost/no vacuum during an atec biopsy procedure.This issue can be discovered during the inspection of the canister during setup or via a system vacuum error when testing the eviva or atec biopsy needle. from customer complaints received to date there has not been any patient harm or other safety issue. however, the issue may prevent the system from enabling a procedure to continue.
  • Acción
    Hologic is advising users to inspect stocks and quarantine all affected units. Hologic will arrange for affected stock to be recovered and replacement stock, or a credit note, to be issued.

Device

ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)
  • Modelo / Serial
    ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)Lot Number: 20150013ARTG Number: 215794
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd