Events

Retiro De Equipo (Recall) de Philips IntelliSpace PACS 4.4

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 Healthcare Informatics Inc.

¿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
    17290
  • Fecha de inicio del evento
    2014-09-03
  • 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
    A problem has been detected in the philips intellispace pacs 4.4 software that, if it were to occur, could pose a risk for patients. although the data is correct in intellispace pacs, any changes to data may not be updated before auto export. if diagnosis is performed utilizing exported data on a 3rd party device the user may not be aware of any unchanged patient. if this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient.
  • Acción
    Software to be upgraded

Device

Philips IntelliSpace PACS 4.4

Manufacturer

Philips Healthcare Informatics Inc
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA