Events

Rappel de SYST BRIGHTVIEW X WITH CRYSTAL 3/8"(UPGRADEABLE VERSON)

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
    39341
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-11-07
  • 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
    Several software issues which will be corrected with the release of a new software version. 1-following a cardiac scan and when using smartstep to setup the camera for a relative 180 procedure it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed. this affects only the brightview xtc systems. 2-during a patient spect lung acquisition the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degee position. however in the middle of a clinical scan acquisition the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degrees to the 240 degrees may take approximately 7 seconds. 3-at the completion of a thyroid procedure the operator executed the pinhole pre-programmed motion (ppm) and noticed a change in the sequence of motions between the imaging pallet and the detector radius. the system moved the patient pallet from the gantry before the detector installed with the pinhole collimator was moved out of the path of the patient. this sequence of motions differed from the previous software release. this affects systems with software version 1.2.3/2.5.3.

Device

SYST BRIGHTVIEW X WITH CRYSTAL 3/8"(UPGRADEABLE VERSON)
  • Modèle / numéro de série
    Model Catalog: 453560829241 (Lot serial: ALL); Model Catalog: 2170-3002A (Lot serial: ALL); Model Catalog: 2170-3000A (Lot serial: ALL); Model Catalog: 453560749161 (Lot serial: ALL); Model Catalog: 453560462131 (Lot serial: ALL)
  • Description du dispositif
    SYST BRIGHTVIEW X WITH CRYSTAL 3/8" (UPGRADEABLE VERSION)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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