Events

Retiro De Equipo (Recall) de MX 16-Slice (Full body CT system)

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-00849-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-12
  • 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-2013-RN-00849-1
  • 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 a report stating that a doctor received a finger pinch from the table top, which resulted in injury. the injury occurred when the doctor placed their hand at the end of the table top. the operator of the system did not notice that the doctor's finger was positioned at the pinch point when they started the movement of the table top.
  • Acción
    Philips will be providing additional warning labels and instructions to users to prevent this issue from occurring. In the interim, Philips Healthcare is advising users to ensure CT scanner room access is controlled by procedures and policies that identify authorised personnel, and includes that patient or bystanders are to keep hands away from the table top when moving. Philips is advising operators to observe the status of patient or bystander when operating the control panel and CT-Box to control patient table.

Device

MX 16-Slice (Full body CT system)

Manufacturer

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