Events

Retiro De Equipo (Recall) de GE Healthcare MRI systems with superconducting magnets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty 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-2015-RN-00103-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-06
  • 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-2015-RN-00103-1
  • 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 mru (magnet rundown unit) is a critical safety component of the mr system that quenches the magnet (i.E., makes it non-magnetic) in emergency situations, such as those that can occur when a ferrous (metal) object is brought into the magnetic field.At certain sites, the mru may not be connected to the magnet. if the mru is disconnected, the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times. further, there is potential for a patient to sustain injury while trapped against the mr scanner.
  • Acción
    GE Healthcare has provided instructions to assist end users to determine if the MRU is properly connected. If the MRU is not connected it is recommended that the MRI is not used and GE Healthcare is contacted immediately. GE Healthcare will inspect all affected systems and ensure the MRU is properly connected to the magnet. This will be performed by GE Healthcare service representative who will contact affected customers to arrange for this inspection and correction if needed. This action has been closed-out on 1/06/2016.

Device

GE Healthcare MRI systems with superconducting magnets

Manufacturer

GE Healthcare Australia Pty Ltd