Events

Retiro De Equipo (Recall) de IMRIS Operating Room table (ORT300)

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-2014-RN-01078-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-07
  • 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-2014-RN-01078-1
  • 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
    Emergo australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material due to an incident at a health care facility in the united states. one of the three pins that is used to hold the ort200 table alignment block in place on the floor of the mr suite went missing and was not accounted for by or personnel. during testing the missing pin was pulled into the magnet, damaging the image quality phantom and headrest extension. no injury or death occurred as a result of this incident.
  • Acción
    Emergo Australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material. A field engineer will be sent to the customer site to replace the pins. This action has been closed-out on 06/06/2016.

Device

IMRIS Operating Room table (ORT300)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia