Events

Retiro De Equipo (Recall) de OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 (mobile flouroscopic x-ray diagnostic system)Systems supplied in Australia:System: OEC 9800

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-01072-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-03
  • 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-01072-1
  • 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
    There are potential safety issues due to part replacements associated with certain components as follows: safety issue #1: the workstation cover may be able to be removed without the use of a tool. if the workstation front cover is removed, the user could be exposed to high voltage resulting in an electric shock. safety issue #2: surge suppressor board may have been replaced with an earlier revision. if the surge suppressor board is subjected to high voltage surges, damage to surge suppressor board components may occur and prevent the system from booting.Safety issue #3: solid state drive may have been replaced with a magnetic hard disk drive. the magnetic hard disk drive is more susceptible to data corruption that may prevent the system from booting.Safety issue #4: workstation power cable may have been replaced with an earlier revision which contains an unnecessary connection that could be subject to a potential connection failure, and prevent the system from booting.
  • Acción
    A GE Healthcare Field Engineer will contact customers to coordinate an inspection of the affected part/s, replacement of the affected part/s if necessary, and will ensure that systems meet the specifications. Work around instructions have been provided in the interim for each of the safety issues identified above. This action has been closed-out on 07/06/2016.

Device

OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 (mobile flouroscopic x-ray diag...
  • Modelo / Serial
    OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 (mobile flouroscopic x-ray diagnostic system)Systems supplied in Australia:System: OEC 9800Serial Number: 86-1220Sysem: OEC 6800Serial Number: 89-2550ARTG Number: 132698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd