Events

Retiro De Equipo (Recall) de OmniDiagnost-Eleva and OmniDiagnost-Classic

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-00595-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-18
  • 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-00595-1
  • 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 has received reported instances in which the table of the omnidiagnost system (od-eleva) suddenly started to rotate from 0 to 90 degrees (table arm down) with high speed. the cause of this unexpected rotation movement is related to an issue with the fixation of the upper and lower tilt actuator. this rotating movement cannot be stopped by the user.If the system rotates uncontrolled, there is a risk of injury for the patient on the table. a rotating table also might hit a user or bystander standing near the system.
  • Acción
    Philips is advising they will be in contact with users to replace affected components on the upper and lower tilt actuator in the impacted systems. It is expected that this action will commence July 2018. In the interim, users should monitor the tables for any of the following, stop use of, and contact Philips immediately if they occur: - the table height or tilt movement is not working; - a cracking or snapping sound is heard during system operation; - a blockade is experienced in the table height or tilt movement during system movements; - the system is having an unexpected collision or the system had an unexpected collision in the past 2 months; - a CPR stand that obstructed the system when in use,; or - any (other) unusual system behaviour beyond the normal use of the system.

Device

OmniDiagnost-Eleva and OmniDiagnost-Classic
  • Modelo / Serial
    OmniDiagnost-Eleva and OmniDiagnost-Classic System Codes: 708026, 708027, 708028, 20859, 708023, 708024, 708025ARTG Number: 98560(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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