Events

Retiro De Equipo (Recall) de Ysio Systems (X-ray 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-2014-RN-00558-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-16
  • 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-00558-1
  • 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
    If excessive liquid is used for cleaning, the liquid may infiltrate the generator console and cause a short circuit which may lead to an unintended release of radiation. to date, only one customer has reported this occurrence.
  • Acción
    Siemens has prepared a modification to resolve the potential issue by sealing the generator consoles of the Ysio Systems against infiltration of liquid. This modification will be installed as field correction likely to occur during 2nd to 4th quarter 2014. Until the modification is implemented, users are advised to strictly follow the user manual to avoid liquid infiltration into the generator console. This action has been closed-out on 18/08/2016.

Device

Ysio Systems (X-ray system)
  • Modelo / Serial
    Ysio Systems (X-ray system)Catalogue Numbers: 10281013 & 10281163ARTG Number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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