Events

Retiro De Equipo (Recall) de Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

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
    17514
  • Fecha de inicio del evento
    2014-10-10
  • 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
    This field safety notice to inform customers that software was upgraded from version 3.X to version 4.0.0 / 4.0.1, the protocol conversion can result in incorrect scan parameters, which in turn can result in delayed images, when using the cct option. report that first image was marked as "last shot" rather than the actual "last shot" acquired. after the clinician pressed the pedal for first exposure, images were displayed as the "last shot". subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labeled as the "last shot". eventually all images appeared., the problem is caused by incorrect slice increment settings in the user set for cct protocol resulting from the protocol to exam card conversion during the software upgrade from v3.X to v4.0.0 / v4.0.1.
  • Acción
    Manufacturer to issue advice regarding use

Device

Philips Ingenuity CT, Ingenuity Core and Ingenuity Core 128

Manufacturer

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