Events

Avis De Sécurité sur iGUIDE® 2.1, iGUIDE® 2.2

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 Medical Intelligence Medizintechnik GmbH.

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
    If by mistake the initial pre-treatment imaging was performed before the hexapod was moved to the drive (*start) position, iguide offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data. this should avoid the need to redo imaging with hexapod in drive (*start) position. in this scenario the software may prompt you several times to move the hexapod to its drive (*start) position. if you follow this request the hexapod will move to drive (*start). in a consecutive step iguide shows hints to move the couch top with the precise table back to the initial imaging position. however, this position is reached only with a coarse movement. a final fine adjustment move, executed by the hexapod, is missing. the coarsely reached imaging position becomes the new registered position for the actual position error correction (pec) movement to the target position. a theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement. .

Device

iGUIDE® 2.1, iGUIDE® 2.2

Manufacturer

Medical Intelligence Medizintechnik GmbH
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    AMPMDRS