Events

Retiro De Equipo (Recall) de Masimo uSpO2 and HPLP Oximeter Cables

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 Respironics 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
    18760
  • Fecha de inicio del evento
    2015-06-29
  • 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
    A small number of oximetry cables have been identified with crossed-internal wires. the effect on performance when these wires are crossed is that when a low spo2 value is measured, a high spo2 value would be displayed on the monitoring device. additionally, with the same oximetry cable, when a high spo2 value is measured, a low spo2 value would be displayed on the monitoring device.
  • Acción
    Product to be returned to supplier

Device

Masimo uSpO2 and HPLP Oximeter Cables
  • Modelo / Serial
    Model: 1075383, Affected: All lots
  • Manufacturer
    Respironics Inc

Manufacturer

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