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
    73927
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-12-24
  • 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 several software issues which will be corrected with the release of a new software version. problem 1: when positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly by an operator causing an inappropriate rotation orbit calculation for the patient being imaged. when the acquisition was started and the detectors began to move into position the incorrect calculation resulted in the detectors coming in contact with the patient. problem 2: on separate occasions as the gantry system was moving to a relative 90 scan position of the detectors a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator. problem 3: while a user was manually positioning the patient for their exam and translating the pallet into the gantry bore the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher. this problem can only occur on the brightview x or the brightview xct system.

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: 453560462131 (Lot serial: ALL); Model Catalog: 453560749161 (Lot serial: ALL); Model Catalog: 2170-3000A (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