Events

Retiro De Equipo (Recall) de Philips Brilliance 64 and Ingenuity CT/Core/Core 128 CT 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 (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
    20197
  • Fecha de inicio del evento
    2016-05-25
  • 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
    1.Though internal testing the image orientation labels( l/ra/p) are not displayed during active scanning when switched from overview layout for volume interventional procedures., 2.Artifacts in the brain scans could be interpreted as finding hypo dense at bone brain interface while scanning using high resolution scan mode., 3. software issues found in the field and through internal testing were indentified on ict and ingenuity/ brilliance 64 with software v4.1.3 and 4.1.4., 4. varian rpm drive is not mapping in ct user profile after logout/login.
  • Acción
    Software to be upgraded

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core 128 CT Systems
  • Modelo / Serial
    Model: , Affected: , Software version: CT systems running software V4.1.3, 4.1.4, or 4.1.5
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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