Events

Alerte De Sécurité sur Trade name: ELEKTA PLANNING SYSTEM Technical name: 2901010 Software de Planej. of Trat. P / Radiation Therapy ANVISA Registration Number: 80569320003 Class of Risk: III Model Affected: Monaco

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par IMPAC Medical Systems, Inc..

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
    2069
  • Date
    2016-12-27
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to the company, it is necessary to read and return the knowledge report of the Important User Notifications to Elekta within 30 days. Request collaboration with Elekta representative to implement the solution as soon as possible. The problem does not occur every time the delete function is used in combination with the contour editing tools. Additionally, because of the complexity of the problem, it is not possible to enumerate all the workflows in which it can occur. However, you can avoid triggering the problem by embedding one of these sequences of steps into your overall workflow with the outline: 1. Delete before editing: In newly generated contours, delete any unwanted contours and save before editing (move, rotate, change format) 2. If you need to delete anything after the edits, save and download the data before deleting. This allows the affected code to find all the coordinates of the contour points. 3. Delete the outline and start over. 4. Clean the contour and start again.
  • Cause
    Changes in outline (edit and delete) no saved from program. according to the company, in a specific workflow where the contours are edited (augmented, moved, copied, etc.), then deleted in parts and then saved in the same session, it is possible that the deleted contours continue in the document, which was not to happen with the program. if a patient file is closed without saving and opened again, the bev will display, in a later created plan, the contours as if they were still there while the transverse, sagittal and coronal views will display the outlines as deleted. the total volume of the reported structure of the dvh will not coincide with structure control. if the study is saved and reopened before a new plan is created, the total volume of the structure reported in the dvh and structure control is corrected. a similar workflow can cause the defect if changes are made while the plane is loading.
  • Action
    Field Action Code FCA-IMS-0016 triggered under the responsibility of Elekta Medical. Company will make correction in the field.

Device

Trade name: ELEKTA PLANNING SYSTEM Technical name: 2901010 Software de Planej. of Trat. P / Radia...

Manufacturer

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