Events

Alerta De Seguridad para ICON P and ICON AP Autoperfusion Workstation Software Version 1.2 designated for use with E.Cam CT with Computerized Emission Systems

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Medical Solutions USA Inc Nuclear Medicine Group.

¿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
    556
  • Fecha
    2002-03-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Under certain conditions, the above software may store the data in progress (gated data) instead of the cumulative data used in the last period (nongated). this will occur if the user processes the user to process a simple self perfusion study, and select the save composite option, saving the results of the current page instead of the entire process page. the manufacturer initiated a field correction by letter dated june 26, 2002.
  • Acción
    Check that you have received the letter of correction dated June 26, 2002, Siemens self-infusion warning letter. Identify and isolate any affected product in your inventory. The intended use of the cardiac revision application is to evaluate the combined data of stress (gated or nongated) and rest. Saved data is stored in a composite file, which is used to view images within the cardiac review application. If the user chooses to revise only a single current set (gated), or user must choose the "save composite" option from the processing page, not from the results page. If your Auto Perfusion software version is 1.2, and has not been upgraded to version 1.3, always save it on the processing page, not on the results page, when processing a simple dataset. The manufacturer requests that you share this information with all other ICON users on your premises. For more information, contact the Siemens Service Center. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

ICON P and ICON AP Autoperfusion Workstation Software Version 1.2 designated for use with E.Cam C...

Manufacturer

Siemens Medical Solutions USA Inc Nuclear Medicine Group
  • Source
    ANVSANVISA