Rappel de GEMINI TF BIG BORE PET/CT IMAGING SYSTEM - MAIN UNIT

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

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
    43459
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-06
  • Pays de l'événement
  • 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
    Issue #1: when a single contour is saved in edit mode tumorloc does not save the contour in the correct location. the contour is saved in the location of the same slice where the last contour was drawn for the last region of interest (roi) in the roi list. a misplaced contour then results in a misplaced isocenter or incorrect field size. this occurs when using the save button exit button or sendtolaser button. issue #2: when the region of interest (roi) is displayed on the beam's eye viewer (bev) in outline mode and the roi color is changed the color is changed in the multi-planar projection (mpr) viewers but not the bev viewers. issue #3: tumor loc-created datasets are flipped and incorrectly labeled when non-gated data is loaded along with pulmonary gated data and is used to create intensity projection datasets (mip minip or avgip). if the clinician obtains a clinical intensity projection dataset in a certain manner a dataset can be generated that is flipped left to right. the resulting dataset is flipped and incorrectly labeled left-to-right when displayed in a viewer.Issue #4: duplicate region of interest (roi) or isocenter names can be created in tumor loc. this duplication is only possible when using the copy feature or manually naming a roi with the suffix " copy". this duplication can be created when creating a new isocenter or roi then creating another new isocenter or roi and naming the second isocenter or roi "firstname copy" (either manually or by clicking copy on the first isocenter or roi) where "firstname" is the name of the first isocenter or roi. if the user then selects the first isocenter or roi and clicks copy the resulting copy has the same name as the second isocenter/roi: "firstname copy".

Device

  • Modèle / numéro de série
    Model Catalog: 4598 001 18561 (Lot serial: 9224); Model Catalog: 4535 679 94741 (Lot serial: 7103)
  • Description du dispositif
    GEMINI TF BIG BORE PET/CT IMAGING SYSTEM
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
  • Source
    HC