Events

Alerta De Seguridad para Image Archiving and Communication System - PACS, Model Syngo Imaging XS; Registration 10234230146, Serial Numbers: Annex to the alert.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; SIEMENS AG.

¿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
    1485
  • Fecha
    2014-12-11
  • 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
    The record holder informs that an invalid printer combination and the syngo Imaging XS printer conversion file may cause incorrect anatomical size printing.
  • Causa
    Prints can be printed at incorrect anatomical size if you use the syngo imaging xs film application to print at anatomical size with a printer not suitable for anatomical printing. this can happen due to an invalid printer combination and the syngo imaging xs printer conversion file.
  • Acción
    The company advises customers to calculate the distance measured in the print through the scale contained in the right-hand end of the print. The distance between two graduation lines corresponds to one centimeter in the anatomy represented. If anatomical printing is unsuitable contact your Regional Representative for proper printer information. Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.

Device

Image Archiving and Communication System - PACS, Model Syngo Imaging XS; Registration 10234230146...

Manufacturer

Siemens Ltda.; SIEMENS AG
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA