Events

Retiro De Equipo (Recall) de CIOS ALPHA

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

¿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
    147593
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-05
  • 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
    The following user actions may cause the system to freeze and the system may become temporarily inoperable: -when images were transferred from the left monitor to the right monitor (function a to b) during image acquisition (i.E. radiation on) or shortly before starting image acquisition. - when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress. - when scene replay was initiated either automatically or by pressing the "play" button (especially when pressing the "play" button more than once) while the storing of those scenes was still in progress. - when image acquisition was initiated again before automatic replay of the last scene started. - when finalized cd/dvds were used to store additional data. - when radiation summary reports with more than 190 entries were being exported. - when system restart was initiated when the error message "system blocked. turn system off/on" (error codes 215/80 and/or 208/80) was displayed. if a system freeze occurs a system reset is required to resume fully operation. this process may take approximately 4 minutes. during the reset process no x-ray imaging is available at cios alpha mobile c-arm x-ray system.

Device

CIOS ALPHA
  • Modelo / Serial
    Model Catalog: 10308191 (Lot serial: 10071)
  • Descripción del producto
    CIOS ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC