Events

Alerta De Seguridad para SPECT / CT EQUIPMENT SYMBIA MARCA SIEMENS, Model Symbia T, T2, T6 and T16; Registration 10234230128 - Lot 1036; 1041; 1057; 1058; 1124; 1200; 1171; 1156; 1202; 1238 and SPECT SYSTEM, Model Symbia S; Registration 10234230167 - Lots 1473; 1534; 1772; 1777; 1803

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 Ltda.; SIEMENS Medical Solutions USA, Inc..

¿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
    1465
  • Fecha
    2014-11-07
  • 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 if an unintentional radial movement occurs, there is a possibility of causing compression-related injury to the patient. However, the Symbia S or Symbia Intevo system is designed to detect such faults and automatically shut down. If the system disconnects with the message "System requires service. Please contact your customer service representative." (the system requires service, contact your customer service representative), the system is disabled until the service technician has deleted the error manually
  • Causa
    Siemens is sending a statement to customers of symbia t and symbia s systems to inform them of a future safety inspection to prevent unintended radial movements of the detectors. the symbia s or symbia intevo system is designed to detect such faults and turn itself off automatically. if the system disconnects with the message "system requires service. please contact your customer service representative." the system is deactivated until technical assistance eliminates the error manually; it is necessary to contact the technical assistance (customer service representative). technical service inspection will determine which systems have been affected and replacement of affected parts will correct the error and the system will return to its original factory performance.
  • Acción
    The company directs the customer to wait for the system inspection to be scheduled by the Service Team, while the system can normally be used in compliance with the Caution and Warning instructions in the user manual. Siemens also recommends observing the patient throughout the procedure and filing the letter with the Operator's Manual

Device

SPECT / CT EQUIPMENT SYMBIA MARCA SIEMENS, Model Symbia T, T2, T6 and T16; Registration 102342301...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; SIEMENS Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA