Events

Rappel de CS 8100 3D

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARESTREAM HEALTH CANADA COMPANY.

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
    20255
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-01-23
  • 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
    Carestream has identified an issue related to the manufacturing process of cs 8100 and cs 8100 3d tomographic digital panoramic x-ray systems manufactured between june 2012 and september 2014 which could result in the head unit descending unexpectedly and contacting the patient. the issue was found at an installation and nobody was injured. it has been determined that the root cause was a circlip (retaiing clip) on a pin used to mate the lower and upper portions of the stand not being fitted at the time of manufacture. this allowed the locating pin to move out of position within the location hole during transportation. there is no hazard during transport and the issue would now be found at any new installation. testing has shown that even without both circlips fitted the pin does not fall out during use but could move therefore to ensure all installed devices are not affected and will perform as designed through their expected life a field inspection recall is being initiated.

Device

CS 8100 3D
  • Modèle / numéro de série
    Model Catalog: 5311162 (Lot serial: CIID071); Model Catalog: 531 1329 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 530 3045 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    CS 8100 3D
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Adresse du fabricant
    VAUGHAN
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    HC