Events

Safety Alert for radioactive therapy management system - Aria

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

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
    I1511-504
  • Event Number
    2014DM-0011561
  • Date
    2015-11-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=168
  • Notes / Alerts
    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.
  • Extra notes in the data

Device

radioactive therapy management system - Aria
  • Model / Serial
    Software versions 10.X, 11.X, 13.0 and 13.5 with clinical evaluation license
  • Product Description
    The management of Aryan radio therapy is a series of software modules designed to handle the entire process of a patient's treatment course, which includes plans for treatment and handling of images allowing the authorized user to enter, access, modify, store and archive treatment data. administrative clinical images and storage. The information can be downloaded from the corporate system, diagnostic images, planning of treatments, simulation, verification and treatment. The management of radioactive Aryan therapy stores histories of treatment including the dose delivered in specific sites, providing the necessary tools to verify the treatments carried out. The management of Aryan radiotherapy is designed to help the oncology personnel in the management of the total course of patient treatment, approval of treatment plans, and execution of the quality assurance review of the treatment, that is, following up on the treatments applied and dosing applied to the specific site. Indications for use include any disease or condition treatable with radiation therapy, including but not limited to cancer, use of aria. Aria password: You need a username and password to start using aria. The system administrator creates a username and password in data administration (data management). Radiation therapy management ARIA DICOM RT DICOM RT is a DICOM interface that allows treatment plan data to be transferred between the external system (basically a treatment planning system) and the Aryan system. The data transfer interfaces are: ARIA LINK, DICOM, MULTI-VENDOR DICOM SERVIS (MVDS) ARIA DICOM printingThe DICOM PRINT printing system allows images to be sent to DICOM printers.Ary description • it is a new workspace that replaces the TAB of prescriptions in the RT box. The users can adapt to specific conditions all the attributes of their radiotherapeutic prescriptions including certain characteristics such as: prescription of multi-modality prescription of multi-energy multiple plans
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA