Events

Retiro De Equipo (Recall) de STEALTH CHAMBER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por IBA DOSIMETRY 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
    69950
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-21
  • 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
    We have identified a potential safety issue related to the stealth chamber as a reference detector for water phantom measurements. when stealth chamber is used as a reference detector in relative dosimetry deviation in the measured pdds at shallow depth and geometric shadowing of measured profiles may appear. customer uses data acquired with stealth as reference chamber to commission treatment planning system (tps) deviations in pdd for large fields and/or higher energies and/or distortions in profiles for large fields go unnoticed and the tps accepts the data and is wrongly commissioned. patients are treated with an inaccurate machine model for large fields. this might lead to mistreatment of patients.

Device

STEALTH CHAMBER
  • Modelo / Serial
    Model Catalog: DS50-00X-XL-T (Lot serial: SN 25219); Model Catalog: DS50-00X-XL-T (Lot serial: SN 24291); Model Catalog: DS50-00X-XL-T (Lot serial: SN 24257)
  • Descripción del producto
    Stealth Chamber
  • Manufacturer
    IBA DOSIMETRY GMBH

Manufacturer

IBA DOSIMETRY GMBH