Events

Retiro De Equipo (Recall) de Measurement Modules

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 Medizinsysteme Boblingen 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
    21944
  • Fecha de inicio del evento
    2017-09-07
  • 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
    The manufacturer has recently discovered that when performing 12-lead ecg monitoring, if an affected monitor detects and alerts the user that the ecg lead set is damaged or otherwise not performing appropriately, it will apply corrective filtering that can distort the st-segment, which could contribute to a misdiagnosis or a misinterpretation causing a delayed or even an incorrect treatment if relied on by the user.

Device

Measurement Modules

Manufacturer

Philips Medizinsysteme Boblingen GmbH
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA