Events

Rappel de INGENUITY CT SYSTEM

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
    130773
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-02-17
  • 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
    Philips has become aware of the following issues: - slab viewer longitudinal location issue - it is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. the following key events must take place for harm to occur: -the patient is placed in a "feet-first" orientation. -an interventional ct procedure is scheduled. -contrary to typical clinical practice a multi-planar reconstruction (mpr) is used for planning the interventional procedure (this issue only occurs in images produced using mpr). -a check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure). -the needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location). - fast get ready issue - fast get ready incorrectly enabled during service procedures. - contrast annotation issue - contrast annotation incorrectly missing for some images when manual contrast was administered. - dot artifact issue - dot artifact present intermittently after startup. - heart rate update issue - heart rate measured value incorrectly remains constant for some heart rate change conditions. - doseright issue - doseright incorrectly enabled when the exam card specified disabling doseright. - tube heat issue - tube heat predictor fails to warn of overheat condition for long scans.

Device

INGENUITY CT SYSTEM
  • Modèle / numéro de série
    Model Catalog: 728326 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL)
  • Description du dispositif
    INGENUITY CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC