Events

Alerta De Seguridad para SOMATOM DEFINITION AS - Model 128-SLICES; 20-SLICES; 40-SLICES; 64-SLICES - Registration Number: 10345161981, Serial Number 66488

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 AG, Siemens 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
    1755
  • Fecha
    2015-11-20
  • 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 company informs that Siemens Healthcare is already analyzing the root cause of this problem and that it will develop a solution for it as soon as possible. In line with the principles of commitment to patient safety, Siemens assumes that as soon as there is an update that eliminates the problem, it will take corrective action.
  • Causa
    Siemens healthcare has recently detected that the combined use of phs1600 (material number 10643655) with perfusion scan mode "adaptive 4d spiral" may occasionally abort scanning on somaton definition as.
  • Acción
    There is only one equipment commercialized in Brazil. Siemens forwarded a letter to the customer alerting the user that he should be aware of the increased risk of aborting a scan by using perfusion scan mode in combination with the PHS1600 table, especially when applying contrast medium. (Code CT045 / 15 / S)

Device

SOMATOM DEFINITION AS - Model 128-SLICES; 20-SLICES; 40-SLICES; 64-SLICES - Registration Number: ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens AG, Siemens Ltda
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA