Events

Retiro De Equipo (Recall) de All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) 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-2015-RN-00573-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-26
  • 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-00573-1
  • 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 spot film device (sfd)/ intelligent digital device (idd) safety mechanism installed on the above systems may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1” (28mm) from the lowest point of normal sfd/idd vertical compression. a fall of the sfd/idd could result in an injury to a patient or operator. there have been no reported injuries as a result of this issue.
  • Acción
    GE Healthcare will correct all affected products. A GE Healthcare representative will contact you to arrange for the correction. The system can continue to be used provided end users: - Perform preventative maintenance in accordance with your product labeling. This includes inspection of the counterweight cables and pulleys every 6 month, and replacement of the counterweight cables every four years. - Set the manual Myelographic stop on the fluoroscopy carriage during exams. This action has been closed-out on 05/08/2016.

Device

All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radio...
  • Modelo / Serial
    All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) SystemsARTG Number: 99423
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd