Events

Rappel de Elekta Mosaiq 2.5

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 Impac Medical Systems 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
    19557
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Cause
    Incorrect drug dosage due to "age limit" data item issue:, when there is no valid (unexpired) patient weight entered on the same date or prior to a serum creatinine value being populated, a stale creatinine clearance (crcl) value is being used in area under the curve (auc) dose calculations., incorrect drug dosage due to patient weight data item issue:, if there is a valid age limit added to an elekta metric data item (eg; weight (kg)) and the same valid age limit has not been added to the elekta imperial data item which corresponds (eg; weight (lb) ), the calculated result which has no valid age will still be considered valid and could be used in drug calculations., if a stale dose calculation is used in dose calculations the dose may be incorrect.
  • Action
    Software to be upgraded

Device

Elekta Mosaiq 2.5
  • Modèle / numéro de série
    Model: Mosaiq, Affected: , Software version: 2.5 and higher
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    NZMMDSA