Events

Retiro De Equipo (Recall) de DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1

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-2012-RN-01208-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-06
  • 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-2012-RN-01208-1
  • 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
    Philips previously notified owners of affected digitaldiagnost systems that software release 2.1.3 would be installed on the systems to modify the appearance of a mirror icon. however, software release 2.1.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side if an image is rotated.Software release 2.1.4 addresses both the original & new issue, & it will be installed on affected systems in place of release 2.1.3. if software release 2.1.3 has already been installed on a system, it will be replaced with release 2.1.4.With digitaldiagnost r 2.0.2 a mirrored “r in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. when such an image is mirrored back inside the pacs system, an unmirrored “r in a circle” appears in the lower left corner. this can be mistaken for a “right patient side” marker, although this can appear on the left patient side.
  • Acción
    Philips Healthcare will be installing a software update to address the identified issue.

Device

DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1
  • Modelo / Serial
    DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1All products with software release 2.0.2 and 2.0.2SP1ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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