Events

Retiro De Equipo (Recall) de Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray 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 Philips Electronics Australia 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-2013-RN-00038-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-15
  • 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-2013-RN-00038-1
  • 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
    Philips healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. philips has determined the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake’s screws.
  • Acción
    If the couch moves down unexpectedly, please discontinue use of the device and contact your local Philips Field Service Engineer. A Philips Field Service Engineer will perform a brake repair or replacement on the affected systems to resolve the issue.

Device

Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iC...
  • Modelo / Serial
    Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)Multiple serial numbers affectedARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA