Events

Rappel de DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR

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
    19852
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • 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 a software defect that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (i.E. radio opaque ruler) when building a composite image and the technologist relies solely on the auto stitching software there could be a risk of undetected stitching error that would otherwise get noticied and corrected with the use of manual stitching.

Device

DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
  • Modèle / numéro de série
    Model Catalog: 1010982 (Lot serial: 5573); Model Catalog: 1731678 (Lot serial: 4569); Model Catalog: 1010982 (Lot serial: 5393); Model Catalog: 1010982 (Lot serial: 5266); Model Catalog: 8001174 (Lot serial: 5408); Model Catalog: 1731678 (Lot serial: 5408); Model Catalog: 8001174 (Lot serial: 4076); Model Catalog: 1731678 (Lot serial: 4076); Model Catalog: 8001174 (Lot serial: 5442); Model Catalog: 1731678 (Lot serial: 5442); Model Catalog: 8001174 (Lot serial: 4879); Model Catalog: 1731678 (Lot serial: 4879); Model Catalog: 8001174 (Lot serial: 4767); Model Catalog: 1731678 (Lot serial: 4767); Model Catalog: 8001174 (Lot serial: 4670); Model Catalog: 1731678 (Lot serial: 4670); Model Catalog: 8001174 (Lot serial: 4588); Model Catalog: 1731678 (Lot serial: 4588); Model Catalog: 8001174 (Lot serial: 4570); Model Catalog: 1731678 (Lot serial: 4570); Model Catalog: 8001174 (Lot serial: 4569); Model Catalog: 1010982 (Lot serial: 5572)
  • Description du dispositif
    DRX-EVOLUTION SYS W/MOTORIZATION-FIXED WALL DETCTR/MOBILE CSI TABLE DETECTR
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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