Alerta De Seguridad para Image Archiving and Communication System (PACS) syngo.plaza, registry 10345162033, risk class I, batch / series list 100180; 100193; 100220; 100222; 100232; 100287; 100313; 100382.

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.

¿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
    1799
  • Fecha
    2016-01-20
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 in case the filing problem occurs, it may generate an incorrect archived study in Long Term Storage. However, non-archived series remain protected against deletion or deletion in Short Time Storage.
  • Causa
    Siemens healthcare has identified that in the event that a user manually removes erasure protection in short time storage for a given series, a partial loss of data (from the affected study) is possible. this is because the user has the impression that the complete study has been archived, however parts of the series not yet archived are subject to the deletion of short time storage.
  • Acción
    Updated software. Action code: SY024 / 15 / S. The company will update the software to correct the problem presented. Until the software is updated, it is to reinforce the need for the erasure block in Short Time Storage (STS) not to be manually removed by the user.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA