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-00209-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-07
  • 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-2018-RN-00209-1
  • 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 imris ort100 and ort300 table rotational locking mechanism may experience a failure. the ort100 rotational locking mechanism can become disengaged or unlocked while in use, which could potentially result in unintended movement of the table due to the older lock design. the ort300 rotational lock may fail to operate such that it cannot change states between locked and unlocked as a result of actuator failure due to improper adjustment of the actuator or the linkage. there have been no reports of injury as a result of this issue.
  • Acción
    Emergo is advising: - for users with ORT 100 tables: the rotational locking mechanism in all affected ORT 100 tables will be replaced with the most current design; - for users with ORT 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary.

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, 10002255ARTG Number: 276861(Emergo Asia Pacific - 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