Events

Retiro De Equipo (Recall) de Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT, Ingenuity Flex 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-2018-RN-00226-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-14
  • 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-2018-RN-00226-1
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch, there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion.This issue occurs frequently after closing e-stop. the motion controller in the couch detects a power problem and disables the horizontal motor, which allows the couch top to free-float*.*the term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion (manual or automatic motion).
  • Acción
    Philips is advising users that once the E-stop has been closed the operator/technologist must initiate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Philips will be conducting an update to permanently correct the issue.

Device

Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iC...
  • Modelo / Serial
    Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT, Ingenuity Flex systemsSerial Numbers: 901001 - 901992,911001 - 911221, 921001 - 921369, 931001 - 931044, 941001 - 941137, 951001 - 951130ARTG Numbers: 98868(Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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