Events

Retiro De Equipo (Recall) de Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems

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-2013-RN-01321-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-13
  • 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-2013-RN-01321-1
  • 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 mobile x-ray system 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/patient. if the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file.
  • Acción
    GE Healthcare is advising users to pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure that the system did not update and select an incorrect exam. GE Healthcare is providing a software upgrade to permanently correct the issue.

Device

Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems
  • Modelo / Serial
    Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray SystemsModel Numbers: 5555000-5, 5555000-6 and 5421698ARTG Number: 201698
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd