Events

Retiro De Equipo O Alerta De Seguridad para Analyzers are immunological: analyzers of the Advia Centaur series, models: Advia Centaur XP

Según Ministry of Health of the Republic of Belarus, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Belarus que fue producido por Siemens Healthcare Diagnostics, Inc., UNITED STATES OF AMERICA.

¿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
    Recall / Safety alert
  • Número del evento
    ИМ-7.97890
  • Fecha
    2014-04-02
  • País del evento
    Belarus
  • Fuente del evento
    MHRB
  • URL de la fuente del evento
    https://www.rceth.by/ru/Safety/MedSafety
  • Notas / Alertas
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 recall data from the U.S. and Belarus.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics carries out corrective actions for the advia centaur xp analyzer and reports the following. when the analyzer's cover is lifted, the cover is supported by a gas spring (smn 10321635) attached to the middle of the cover. over time, the gas spring may lose its effectiveness and not keep the cover in full or partially open position. this may cause the cover to fall during equipment maintenance. thus, the cover can cause injury to the operator if dropped. this fact does not affect the results of research.

Device

Analyzers are immunological: analyzers of the Advia Centaur series, models: Advia Centaur XP

Manufacturer

Siemens Healthcare Diagnostics, Inc., UNITED STATES OF AMERICA
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    MHRB