Safety Alert for Commercial name: Ergo Stereotactic Planning System. Technical Name: Software de Planej. of Trat. P / Radiation therapy. ANVISA registration number: 80569320022. Risk class: III. Affected Model: ERGO ++ Radiation Treatment Planning Software (+ Localyzer). Serial numbers affected: 1.7.3, 1.7.5, 1.7.7, 1.7.8

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta, Inc. (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
    2406
  • Date
    2017-11-10
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    Immediately perform the verification tests included in the warning to ensure that the collimator and positioning stand are running correctly. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 08/16/2017 - Date of notification notice to Anvisa: 10/11/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    Possibility of an incorrect dicom mapping of the exported angles from the collimator or bed to ergo®, which would lead to incorrect rotation of the collimator or bed when using an mlc device for planning. if the dicom export values ​​are not mapped correctly, treatments may be applied at an incorrect angle of the collimator or bed.
  • Action
    Field Action Code FCA-IMS-0025 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. TBD - will make possible update with installation instructions ..