Events

Rappel de Philips Ingenia, Intera and Achieva MR Systems

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 Philips Medical Systems Nederland BV.

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
    16740
  • Date de mise en oeuvre de l'événement
    2014-05-23
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    The cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing., the cross reference lines are correctly displayed on the unfused stations., the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images., the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan.
  • Action
    Software to be upgraded

Device

Philips Ingenia, Intera and Achieva MR Systems
  • Modèle / numéro de série
    Model: Models: Ingenia, Intera, and Achieva, Affected: , Software version: Versions: R5.1.1 and R5.1.2
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

Philips Medical Systems Nederland BV
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA