Events

Rappel de Intelerad InteleradPACS

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 Intelerad Medical Systems Incorporated.

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
    18563
  • Date de mise en oeuvre de l'événement
    2015-05-22
  • 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: Pharmaceutical Marketing New Zealand Ltd, 162 Nile Road, Milford, Auckland 0620
  • Cause
    Images successfully transmitted to intelepacs may not be available for reading in all studies. this failure can be detected if the client has image count verification protocols. this failure can also be detected if complete series are missing as the user will know to look for those missing series. in addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy, which is also highly detectable. however, under certain circumstances it can appear as if the study is complete with no user observable means to identify the failure. no patient incident has been reported to date.
  • Action
    Software to be upgraded

Device

Intelerad InteleradPACS
  • Modèle / numéro de série
    Model: , Affected: Software versions: 4.7.1 R27 and up, 4.8.1 R20 and up, 4.9.1 R17 and up, 4.10.1 R9 and up, 4.11.1 R3 and up
  • Manufacturer
    Intelerad Medical Systems Incorporated

Manufacturer

Intelerad Medical Systems Incorporated