Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by IMPAC Medical Systems, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2069
  • Date
    2016-12-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA