Events

Retiro De Equipo (Recall) de G-scan Brio Magnetic Resonance System

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-2016-RN-00972-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-21
  • 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-2016-RN-00972-1
  • 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 is providing additional safety instructions for the safe use of the magnetic resonance system g-scan brio. the issues could lead to an unsafe exam condition.A potential weakness in the foot rest and the left bed rail of the patient table has been identified. this weakness may lead to a fracture of the patient table within the foot rest and the left bed rail in certain conditions. in particular this may happen if a heavy patient applies a strong dynamic stress (bouncing stress) to these specified areas of the table to access or descend to/from the table. there is a chance of a patient falling, or patient injury to the head or back if this situation occurs.Additionally, there is a potential weakness in the patient seat used for some specific weight-bearing examinations such as shoulder, cervical spine and temporo-mandibular joint, with patients weighing near or in excess of the defined limits. this weakness in the patient seat may lead to a fracture within the seat.
  • Acción
    Emergo is advising users that for non-weight bearing exams, to ensure patients access and descend from the patient table in the defined area. For weight bearing exams, patients must access and descend from the table in a vertical position. Further, the weight limit for weight bearing exams has been reduced to 110kg. Patients weighing over this limit must be examined in a horizontal position. Emergo will be providing updated labelling and IFU to all affected customers. Investigations into a permanent correction are being undertaken by the manufacturer. This action has been closed out on 15 June 2017.

Device

G-scan Brio Magnetic Resonance System

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia