Events

Retiro De Equipo (Recall) de Philips DigialDiagnost X-Ray System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Philips Medical Systems DMC GmbH.

¿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
    13858
  • Fecha de inicio del evento
    2012-11-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    With digitaldiagnost (didi) 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., philips previously notified owners of affected digitaldiagnost systems that software release 2.1.3 would be installed on their systems to modify the appearance of the mirror icon, as described below. 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.
  • Acción
    Software to be upgraded

Device

Philips DigialDiagnost X-Ray System

Manufacturer

Philips Medical Systems DMC GmbH
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA