Events

Rappel de Siemens Digital Linear Accelerators of type Primus, ONCOR and ARTISTE

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 AG.

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
    20516
  • Date de mise en oeuvre de l'événement
    2016-08-17
  • 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
    The manufacturer is informing customers about a new bundled software update that will address multiple issues including issues that have already been previously communicated:, 1. prevention of automatic movements in case of significant risk for collision, 2.Re postioning of 160 mlc after motion stop interlock, 3.Restart of control console, 4. support of tractional monitor units for virtual wedge, 5. transfer of user-defined attributes from one session to another, 6. correction of wrong offset calculation in combination with images acquired with ctvision and also with adaptive targeting option, 7. correction of interrupt of cone beam reconstruction, 8. table rotation values for relative setup, 9. correction of wrong in-session resumption in case of 0 (zero) delivered monitor units, 10. unexpected table movement after internal error message on syngo rt therapist, 11.Update of user documentation "physics primer"., 12.Update of addendum for syngo rt therapist and user documentatio.
  • Action
    Software to be upgraded

Device

Siemens Digital Linear Accelerators of type Primus, ONCOR and ARTISTE
  • Modèle / numéro de série
    Model: 8162815 and 8168754, Affected: , Software version: 12.0.25 or 13.0.65 and 4.2.110 or 4.3.SP
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA