Events

Rappel de CIOS ALPHA

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    147593
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-05-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Model Catalog: 10308191 (Lot serial: 10071)
  • Description du dispositif
    CIOS ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC