Events

Retiro De Equipo (Recall) de Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radiation protection system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens 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-2012-RN-01027-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-10
  • 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-2012-RN-01027-1
  • 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
    A particular component may not have been fitted during the installation of some mavig portegra 2 systems. the component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose, leading to an adverse effect on the function and possibly becoming detached from the system.
  • Acción
    Siemens is advising users that a technician will perform an update to the affected systems.

Device

Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radia...
  • Modelo / Serial
    Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radiation protection system)Part Numbers for the MAVIG PORTEGRA 2 System: 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281153
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA