Events

Alerte De Sécurité sur Elekta linear accelerator

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Elekta Limited || Elekta Instrument Ab.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1609-401
  • Numéro de l'événement
    2009EBC-0005074
  • Date
    2016-09-27
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has determined that when a plan3d of monaco is exported through dicom and the check box "composite field sequencing" (cfs, [field composition sequencing]) is selected, the jaws y are set to the shape of the port, despite that they should continue how and where they were defined. this fact takes place when the shape of the port used to define or edit the positions of the mlc extends beyond or within the actual positions of the jaws, the problem is when a workflow is used for the imrt with direct planning involving the creation of several you do for the same gantry angle with a single mlc shape defined for each beam, these beams then see the cfs to combine the individual 3d beams into a single sequence of imrt beams, leading to an overdosage or receive less than necessary, which could potentially cause the presentation of adverse events on the patient.

Device

Elekta linear accelerator
  • Modèle / numéro de série
    AXESSE, SYNERGY and INFINITY, MONACO software version v5.11 and 5.20, specific serials.
  • Description du dispositif
    This integrated system is designed to ensure that the parameters required for a wide range of radiotherapy techniques and advanced applications are easily achieved.
  • Manufacturer
    Elekta Limited || Elekta Instrument Ab

Manufacturer

Elekta Limited || Elekta Instrument Ab
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    NIDFSINVIMA