Events

Retiro De Equipo (Recall) de IMRIS ORT100 and ORT300 Operating Room Tables

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-00208-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-21
  • 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-00208-1
  • 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
    The ort100 and ort300 tables may drift while in use, which could potentially result in unintended movement of the table. the drift occurs slowly over time and typically is not recognised until after several hours. there have been two reports of injury overseas as a result of this issue.
  • Acción
    Emergo is advising that the following corrective actions will be undertaken: · ORT100: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do no pass the drift test, a hydraulic fluid flush and filter change will be performed. · ORT300: All customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed. A drift test will also be performed.

Device

IMRIS ORT100 and ORT300 Operating Room Tables
  • Modelo / Serial
    IMRIS ORT100 and ORT300 Operating Room TablesPart Numbers: 110470-000 and 114093-000Serial Numbers: 10003241 and 10002255ARTG Number: 276861Emergo Asia Pacific T/a Emergo Australia - Table, x-ray system, diagnostic, general-purpose, powered
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia