Events

Retiro De Equipo (Recall) de Allura Xper R8.2.0 (Fluoroscopic diagnostic 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 Philips Electronics Australia 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-00812-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-22
  • 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-00812-1
  • 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
    As result of a faulty automatic motion controller (amc), a problem in the power on self test (post) error handling was detected, which can result in a hazardous movement of the c-arc. this can only occur during startup of the system. when the problem in the post error handling during startup occurs, the c-arc might move unexpectedly. the image detector (which is connected to the same amc axis motion controller) may also move unexpectedly. the issue does not occur at every startup and is only present if a post-error handling is detected during the post phase.
  • Acción
    Philips is advising that the user must be cautious for any unexpected movement of the C-arc and Image Detector when a system start-up (cold restart) is required during a procedure to protect their own safety and the safety of the patient on the table. Philips field service engineers will install software release R8.2.0.3 which addresses the Positioning Software to respond properly to this error reported by the AMC motion controller during startup of the system. This action has been closed on 05/08/2016.

Device

Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA