Events

Alerta De Seguridad para SOMATOM DEFINITION AS and SOMATOM DEFINITION FLASH Technical Name: CT Scanning Equipment ANVISA Registration Number: 10234230157 Hazard Class: III Model Affected: SOMATOM DEFINITION AS and SOMATOM DEFINITION FLASH Serial numbers affected: 64127; 64147; 64584; 64665; 64948; 64981; 64988; 65055; 65160; 65227; 65395; 65405; 65422; 65431; 65477; 65571; 65584; 65585; 65621; 65648; 65675; 65682; 65901; 65910; 65950; 65987; 66149; 66397; 66401; 66430; 66479; 66488; 66492; 66524; 66584; 66586; 66590; 66782; 73105; 73172.

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
    2087
  • Fecha
    2016-10-31
  • 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 operator must not use the CT system if the laser marker window is not present or is loose. In addition, please inform the Siemens Service Center.
  • Causa
    Siemens has identified that in rare cases the small window of the light marker used for the positioning laser and integrated into the front cover of the ct system may become loose and possibly fall.
  • Acción
    Field Action Code CT031 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

SOMATOM DEFINITION AS and SOMATOM DEFINITION FLASH Technical Name: CT Scanning Equipment ANVISA R...

Manufacturer

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