Events

Rappel de UROSKOP OMNIA

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
    48072
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-08-28
  • 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
    1.) during a rad examination with automatic exposure control a highly unlikely malfunction can result in longer radiation exposure than required. this may also result in an overexposed image that is not of diagnostic quality resulting in the examination needing to be repeated. statistically this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode. the automatic exposure control is used less frequently with the uroskop omnia therefore reducing the risk that such malfunction might occur. 2.) when selecting a tomo ogp in some cases the luminos drf system shows a message "wait for flc" and this state does not change on its own. 3.) sporadically it may occur that the radiation is not activated and therefore an exposure is performed without radiation. in case of a scan sequence at luminos drf the complete sequence might have to be repeated.

Device

UROSKOP OMNIA
  • Modèle / numéro de série
    Model Catalog: 10094910 (Lot serial: S/N 3071); Model Catalog: 10094200 (Lot serial: 16 UNITS CONTACT MFR FOR S/N)
  • Description du dispositif
    UROSKOP OMNIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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