Events

Rappel de ULTRA-SPEED DENTAL INTRAORAL FILM

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
    34797
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-06-26
  • 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 incorrect orientation of the indicator dot on dental intraoral film packet labeling of some lots of insight item 811 0785 (size 0 packet) ib-01 and some lots of ultra-speed item 834 8658 (size 0 packet) df-48. the indicator dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. this issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. the result is the image orientation will be rotated 180 degrees. the remaining content on the label is correct. image quality is not affected by this issue.

Device

ULTRA-SPEED DENTAL INTRAORAL FILM
  • Modèle / numéro de série
    Model Catalog: 834 8658 (Lot serial: 333-012-01); Model Catalog: 834 8658 (Lot serial: 333-012-02); Model Catalog: 834 8658 (Lot serial: 333-012-03); Model Catalog: 834 8658 (Lot serial: 343-015-01); Model Catalog: 811 0785 (Lot serial: 538-013-03); Model Catalog: 811 0785 (Lot serial: 539-012-01); Model Catalog: 811 0785 (Lot serial: 545-012-01); Model Catalog: 811 0785 (Lot serial: 546-012-01)
  • Description du dispositif
    ULTRA-SPEED
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

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