Events

Avis De Sécurité sur Monaco running version 3.1 and higher

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par IMPAC Medical Systems, Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    For certain workflows where you edit contours (zoom in, move, copy, etc.) and then delete and save the contour on some slices in the same session, deleted contours may still be present, which the planner did not intend. if you did not save and retrieve the patient, the contours in the beam view (bev) in the newly created contour plan will still be present and the contours, center, and front will be displayed as deleted. the total amount of structures displayed in dvh and in structure management does not match.

Device

Monaco running version 3.1 and higher

Manufacturer

IMPAC Medical Systems, Inc.
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    AMPMDRS