Events

Rappel de Carestream PACS Client Workstation

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
    15496
  • Date de mise en oeuvre de l'événement
    2013-10-16
  • 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
    Carestream health has received one report from overseas where under very specific conditions, some images from multi-slice studies such as ct and mr may not load into the viewer application. an incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios. this problem occurs infrequently and only when all of the following conditions are met:, 1) the version installed is v11.3.2 or v11.3.2.4 or v11.4, 2) the exam type is from multi-slice modalities, 3) the images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images., 4) a timing conflict occurs between 2 processes responsible for the load of images into memory.
  • Action
    Software to be upgraded

Device

Carestream PACS Client Workstation
  • Modèle / numéro de série
    Model: Catalogue numbers: 1308519, 1530633, 1467067, 1405794, 8171837, Affected: Software Versions: 11.3.2.0 / 11.3.2.4 / 11.4
  • Manufacturer
    Carestream Health Inc

Manufacturer

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