Events

Retiro De Equipo (Recall) de Philips IntelliVue Information Centre (PIIC)

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 (USA).

¿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
    19578
  • Fecha de inicio del evento
    2015-12-15
  • 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
    Calcualated leads, also referred to as reconstructed ecg leads viewed or printed at the information centre ix may misrepresent the ecg waveform in specific leads., lead combinations that are affected:, lead 1 and lead 111 are used to derive the avl lead (incorrectly derived), lead 1 and lead avr are used to derive the avl lead (incorrecty derived)', lead 111 and lead avf are used to derive lead 11 (incorrecty derived).
  • Acción
    Software to be upgraded

Device

Philips IntelliVue Information Centre (PIIC)
  • Modelo / Serial
    Model: 866023 Intellivue Info Center iX, 866117 PIIC Classc Upgrade and 866389 IntelliVue Info Center iX, Affected: all versions
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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