Alerta De Seguridad para XiO RADIATIONS TREATMENT PLANNING SYSTEM - Registered in Anvisa under the number 80186820002 - Version 4.3.0 and above - Medintec Ltda.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medintec Latin America Ltda..

¿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
    974
  • Fecha
    2009-08-03
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    The dose distribution calculated for a beam must remain associated with that beam regardless of whether or not the beam is renumbered. The problem may occur when a new dose calculation is performed, the bundles are renumbered and the dose is just added again. This is due to how the dose files are renumbered. When a new beam number is entered, the original dose files are copied to a different location. Once the beams are remunerated, the dose files are copied back to the original location and assigned a new name based on the new beam number. During the process of copying these new dose files to the renumbered beams, it is possible that the new dose number is assigned to the wrong dose file. Such a problem will not occur if a complete recalculation is carried out. In many cases, the discrepancy between the beam and the dose distribution will be obvious. However, if a recalculation does not occur, it is possible to approve a plan based on an incorrect dose distribution for the beam configuration.
  • Causa
    The system developer has learned that version 4.3.0 and above the software, when renumbered, the bundles can enter a state where the dose presented for a beam does not match the placement of the beam on the patient.
  • Acción
    Recommended actions for product users are as follows: (1) After renumbering the beams, make a change that forces recalculation of the dose. This problem exists since XiO Release 4.3.0 and will be fixed in a future edition of XiO. (2) Contact the representative in Brazil: Meidntec Latin America Ltda. - Fax: (11) 4721-1587 or e-mail: aleme@medintec.com.br. The company, in turn, expects that by October 2009 the updated version can be opted for customers. Anvisa is following this action.

Manufacturer

  • Source
    ANVSANVISA