Events

Rappel de Siemens Biograph TruePoint with PET syngo 6.7.x software AND Biograph mCT and mCT Flow 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 Siemens Medical Solutions USA 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
    20091
  • Date de mise en oeuvre de l'événement
    2016-05-03
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    It has become aware, through customer complaint process, that utilizing a phantom other than the siemens solid germanium-68 phantoms may impact the calibration factor values generated during the pet quality control procedure. depending on the type of uniform phantom utilized to perform the pet quality control, the pet calibration factor may be biased due to the system using a specific mu-value of 0.1 cm-1 which is based on the siemens solid germanium-68 phantom. the system will use this default mu-value, regardless of the actual mu-value of the phantom utilized for pet quality control; this may cause a variation in the quantification of the attenuation corrected pet images.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Biograph TruePoint with PET syngo 6.7.x software AND Biograph mCT and mCT Flow systems

Manufacturer

Siemens Medical Solutions USA Inc
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA