Alerta De Seguridad para Allura Xper Radiographic Systems

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips Healthcare.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: philips healthcare allura xper radiographic systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning its allura xper radiographic systems. according to the manufacturer, as a result of a faulty automatic motion controller (amc), a problem in the power on self test (post) error handling was detected, which can result in a hazardous movement of the c-arc. this can only occur during startup of the system. when the problem in the post error handling during startup occurs, the c-arc might move unexpectedly. the image detector (which is connected to the same amc axis motion controller) may also move unexpectedly. the issue does not occur at every startup and is only present if a post-error handling is detected during the post phase. when the system is used to perform clinical interventional procedures, this might cause a harmful situation in which the patient or staff member is being touched by the moving part. the manufacturer advises that user must be cautious for any unexpected movement of the c-arc and image detector when a system start-up (cold restart) is required during a procedure to protect his own safety and the safety of the patient on the table. the manufacturer would provide updated software release r8.2.0.3 which addresses the positioning software to respond properly to this error. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 09 july 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Pedal of footswitch for Philips MultiDiagnost Eleva FD Systems and Allura Xper Systems
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source