Events

Retiro De Equipo (Recall) de Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-ray 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-2014-RN-00121-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-05
  • 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-00121-1
  • 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
    Intermittently when a large number of patient exams are retrieved from the his/ris system, the exams when displayed on the wdr1 are not properly displayed. if the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam or patient. if the user does not notice this change and continues to perform the exam, the images will be placed in the incorrect patient file.
  • Acción
    GE Healthcare are providing work around instructions for users to follow when using the WDR1 based systems for exams. Users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure the system did not update and select an incorrect exam. GE is providing a software upgrade as a permanent fix.

Device

Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-r...

Manufacturer

GE Healthcare Australia Pty Ltd