Events

Rappel de SOMATOM DEFINITION - MAIN UNIT

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
    25800
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2013-12-10
  • 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
    Somatom definition ct systems running software version syngo ct 2012b (va44) may experience a malfunction which may lead to a system display freeze during interventional procedures. when the function "auto save last displayed images as key images" is activated during an interventional procedure the software configuration allows conflicting access to the ct system image database which may cause a system display freeze to occur. when this happens normal interaction with the system is no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognize the malfunction and continue the interventional procedure. in view of the misleading information shown on the display an injury of the patient cannot be fully ruled out.

Device

SOMATOM DEFINITION - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 77 40 769 (Lot serial: ALL); Model Catalog: 8098027 (Lot serial: ALL); Model Catalog: 10590000 (Lot serial: ALL); Model Catalog: 10430603 (Lot serial: ALL)
  • Classification du dispositif
    Radiology Devices
  • Description du dispositif
    SOMATOM DEFINITION -MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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