Events

Retiro De Equipo (Recall) de E.CAM or Symbia E System: Rear Casters of the Collimator Cart

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-00855-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-01
  • 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-00855-1
  • 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
    The rear casters of the collimator cart may become loose and under certain circumstances result in the cart tipping towards the operator. this problem occurs when two conditions are present: 1. the caster has insufficient clamping force and 2. the affected caster passes over a low spot in the floor. if both conditions exist, it is possible the caster will dislodge from the bottom of the cart, allowing the cart to tip backwards toward the operator.
  • Acción
    End users are advised that they can continue to use your system while waiting for the field correction to be scheduled and performed. However, if you suspect a caster is loose, as indicated by shaking while the cart is in motion, discontinue use of the collimator cart and notify your local Service representative. A retention bracket will be installed on all affected devices to correct the problem. This action has been closed-out on 24/05/2016.

Device

E.CAM or Symbia E System: Rear Casters of the Collimator Cart
  • Modelo / Serial
    E.CAM or Symbia E System: Rear Casters of the Collimator CartCatalogue numbers: Collimator Carts 7760908, 7760882ARTG number: 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

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