Events

Retiro De Equipo (Recall) de MultiDiagnost Eleva and MultiDiagnost Eleva with Flat Detector

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-00342-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-23
  • 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-00342-1
  • 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 been made aware of instances in which the table of the multidiagnost-eleva has suddenly started to tilt from 0 to 90 degrees (table arm down) with high speed. the cause of this unexpected movement is related to an issue with the fixation of the upper and lower tilt actuator. in the event the system experiences uncontrolled movements, there is a risk of injury for the patient on the table. a tilting table might also hit the 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. 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

MultiDiagnost Eleva and MultiDiagnost Eleva with Flat Detector
  • Modelo / Serial
    MultiDiagnost Eleva and MultiDiagnost Eleva with Flat DetectorSystem Code Numbers: 708032, 708034, 708036, 708037, 708038Model: MD-Eleva, UD-ElevaARTG Number: 98560Philips Electronics Australia - 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