Alerta De Seguridad para ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis zee ceiling Serial Numbers Affected: 17582

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens Healthcare GmbH.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    Siemens recommends the use of sterilized covers to protect the wireless radar drive pedal from all types of contamination. Since it is already standard practice in many installations, this approach is an effective way to prevent the wireless radius trigger pedal from coming into contact with liquids. When cleaning or disinfecting the radiation trigger pedal, use cloths that are moist but not dripping. You should avoid immersing the wireless radiation trigger pedal into liquids until corrective action has been taken. If the wireless radiation trigger pedal stops working, the radiation delivery for acquisition of images continues to be possible via the manual radiation trigger pedal. Normal emergency procedures should be implemented in case of system failure. Ensure that these processes are prepared in advance until our countermeasures have been implemented. There is no need to re-examine any patients. This is a possible hardware defect that has no influence on the treatment of patients. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    Siemens healthcare diagnostics informs its customers about a potential safety quality issue that affects the use of the wireless radar foot pedal in an artis system. slack in the wireless radar trigger pedal may result in fluid entering the interior. these liquids may include disinfecting or cleaning agents but also body fluids, and may, in rare instances, result in failure of the wireless radiation drive pedal. only the wireless radiation trigger pedals that have been shipped with artis systems after january 1, 2005 are affected.
  • Acción
    Field Action Code AX063 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send letter to the client.


  • Empresa matriz del fabricante (2017)
  • Source