Events

Retiro De Equipo (Recall) de Philips Ingenia, Intera and Achieva MR Systems

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 Nederland BV.

¿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
    16740
  • Fecha de inicio del evento
    2014-05-23
  • 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 cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing., the cross reference lines are correctly displayed on the unfused stations., the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images., the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan.
  • Acción
    Software to be upgraded

Device

Philips Ingenia, Intera and Achieva MR Systems

Manufacturer

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