Events

Rappel de Kodak 2100 and 2200 Intraoral X-ray System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Carestream Health Inc.

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
    16227
  • Date de mise en oeuvre de l'événement
    2014-02-14
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
  • Cause
    The manufacturer advises that it has received advice that there were five incidents overseas where an early failure of the device occurred where pivot/bracket of the arm broke allowing the arm to drop to 90°. the failure is not immediate and would be noted by the user as part of the routine maintenance inspection, before the arm can fall. should the arm fall, there is a risk of injury by impact to the patient or user.
  • Action
    Product to be modified

Device

Kodak 2100 and 2200 Intraoral X-ray System
  • Modèle / numéro de série
    Model: Kodak 2100 & 2200 Intraoral X-Ray System, Affected: Manufactured in China between May 2008 and April 2010
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    NZMMDSA