Events

Rappel de CARESTREAM DRX-1 SYSTEM WIRELESS

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
    45537
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-11-09
  • 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
    A single occurrence of a cross wired appliance connector within a carestream drx-1 system console was discovered during system testing prior to shipment. carestream has determined that a field inspection is necessary to ensure there are no consoles in the field with the cross wiring configuration. if a cross wired console is in use under the combination of circumstances where a facility does not have an intact electrical ground an operator or service person is touching the console and another grounded surface there could be a risk of severe electrical shock. this type of event is very unlikely as all of these circumstances must be true in order for the hazard to manifest.

Device

CARESTREAM DRX-1 SYSTEM WIRELESS
  • Modèle / numéro de série
    Model Catalog: 827 8186 (Lot serial: >10 numbers contact mfg); Model Catalog: 116 8079 (Lot serial: 181); Model Catalog: 8011199 (Lot serial: >10 numbers contact mfg)
  • Description du dispositif
    Carestream DRX-1 System
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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