Events

Retiro De Equipo (Recall) de PINNACLE THERAPY PLANNING SYSTEM - KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    28489
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-08-05
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Philips has become aware that the dose may be inconsistent with the density of a density-overriden roi (region of interest). the issue occurs under certain specific conditions where the user modifies a contour in a density-overridden roi (region of interest with density set to a specific value) in a computed plan dose is subsequently invalidated and the user may recompute the dose. in this case the density can be replaced by the ct number from the ct to density table when recomputed resulting in an incorrect dose and the monitor units (mu) may then be much higher than origianlly planned. the user may continue and save the plan with incorrect dose. when the plan is reopened the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.

Device

PINNACLE THERAPY PLANNING SYSTEM - KIT
  • Modelo / Serial
    Model Catalog: 453560453781 (Lot serial: >10 NUMBERS CONTACT MFG.)
  • Descripción del producto
    PINNACLE THERAPY PLANNING SYSTEM - KIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC