Events

Alerta De Seguridad para radioactive therapy management system - Aria

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por manufacturer #121.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1511-504
  • Número del evento
    2014DM-0011561
  • Fecha
    2015-11-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=168
  • Notas / Alertas
    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.
  • Notas adicionales en la data

Device

radioactive therapy management system - Aria
  • Modelo / Serial
    Software versions 10.X, 11.X, 13.0 and 13.5 with clinical evaluation license
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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