Events

Retiro De Equipo (Recall) de Proteus XR/a X-ray Imaging 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 GE Healthcare 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-2014-RN-01300-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-12
  • 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-01300-1
  • 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
    It was reported that both the steel cables in a proteus system wall stand failed and the bucky cabinet (68kg) fell to the floor. the unit was not in use, no patient or operator injury was reported. the proteus wall stand assembly associated with this event was identified as model 600-0301. the steel cable used with this wall stand is 603-3220. an investigation concluded that the root cause was fatigue of the braided rope.
  • Acción
    1. GE Healthcare will correct all affected systems by replacing the steel cables at no cost. A GE Healthcare service representative will contact customers to arrange for this correction. 2. To prevent occurrence of these issues in the future, the Service Procedures including the service interval for periodic cable maintenance and replacement is also being updated. The updated Service Procedure (2273022-100 Rev 31) will be available by 15th Jan 2015 at a website link that is to be provided in the Customer Letter. This ation has been closed-out on 11/08/2016.

Device

Proteus XR/a X-ray Imaging Systems

Manufacturer

GE Healthcare Australia Pty Ltd