Events

Retiro De Equipo (Recall) de Discovery MR750w (MRI 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 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-2016-RN-00773-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-09
  • 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-00773-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue with the patient bore heating on the discovery mr750w. a small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. this issue has been observed in the situation in which a user has routinely used the system for off center imaging with large patients (for example, off center wrist or shoulder exams) with transmit gain set near maximum levels. there have been no reports of injury as a result of this issue.
  • Acción
    GE is advising users to continue to use the system and follow the existing Operator Safety Information for proper patient padding and observation during scanning. If a brown discolouration is seen on the inner surface of the patient bore or if a burning smell is noticed, discontinue scanning. GE will be correcting all affected units.

Device

Discovery MR750w (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd