Events

Retiro De Equipo (Recall) de OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carl Zeiss 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-2014-RN-00174-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-20
  • 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-2014-RN-00174-1
  • 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
    Based on post-market surveillance of hardware system performance, it has been identified that system components may cause, in rare situations, a blocking of the magnetic brakes or a system freeze/ system restart during operation potentially prolonging surgery.
  • Acción
    Carl Zeiss is providing a software and hardware update to ensure the malfunction does not occur. An enhanced long-term software and hardware maintenance of the OPMI Pentero system procedure is also included in the maintenance package. This action has been closed-out on 28/01/2016

Device

OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, ...
  • Modelo / Serial
    OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010Serial Numbers: 6631402471 to 6631461774ARTG Number: 187127
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd