Alerta De Seguridad para Leksell Gamma Knife® ## ANVISA Record Number: 80569320006 ## Risk Class: III ## Affected: Leksell Gamma Knife PERFEXION ## Serial Number (s) To Handle: LEKSELL GAMMA KNIFE PERFEXION / 17397-001 / 6158 and LEKSELL GAMMA KNIFE PERFEXION / 105528-001 / 6122.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda; Elekta Instrument AB.

¿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
    1865
  • Fecha
    2016-04-14
  • 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 company points out that "The customer (technician) should read the manual and follow exactly the guidelines on page 44 item 3.3.1. If in doubt, consult the Elekta technical service."
  • Causa
    Potentially incorrect mounting of the frame adapter to the stereotactic head-frame may affect product performance. if the frame adapter is placed incorrectly (large displacement) in the stereo head frame, the treatment will fail the target with approx. 1-2 cm. that is, if the frame adapter is incorrectly mounted to the coordinate frame and this is not noticed by the user before the start of treatment, the dose will be delivered in the wrong place.
  • Acción
    Company unleashed Field Action - Security Alert - with the sending of a communication to customers (LETTER TO CUSTOMERS IN ANNEX). Code FCA-EIAB-0004 ## Two units of the equipment have been imported: LEKSELL GAMMA KNIFE PERFEXION / 17397-001 / 6158; LEKSELL GAMMA KNIFE PERFEXION / 105528-001 / 6122 sold respectively to the Heart Hospital of São Paulo (HCOR) and to the company JR Camargo & OO Kaesemodel Filho of Curitiba / PR.

Manufacturer