Events

Alerta De Seguridad para allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20

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
    2011-08-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110804a.html
  • 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
    Field safety notice: philips allura xper systems - allura xper fd10 (f/c), allura xper fd10/10 (incl. or table), allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20 philips healthcare has issued a field safety notice to the customers of allura xper systems. investigation of field problems on the allura xper systems showed that there is a problem related to the harddisk firmware. the hard disk drive itself is working fine but the used firmware suffers from an incorrect incrementing smart counter. this might result in a very high “raw read error” count which will lead in a so called “smart trip” and subsequently will take the hard disk drive offline. consequently the system might intermittently freeze. this can vary from several seconds up to one minute. if during a procedure the system intermittently freezes for several seconds and up to one minute, the system does not generate x-ray anymore and no geometry movement is possible during this period of time. if this happens during a critical phase in a procedure this might lead to a disturbance in the procedure and a possible injury to the patient. this intermittent image freeze / system freeze is not foreseeable or recognizable by the user. the manufacturer recommended customers not to reboot or take any other actions until the system proceeds on its own, because this could slowdown the systems automatically recovery. the manufacturer will provide users a cd with the correct firmware and an installation procedure to implement the corrective actions. according to the local supplier, hong kong is affected. the local supplier is following up the issue with its customers. if you are in possession of the affected product, please contact your supplier (hotline: 2821-5473) for necessary actions.

Device

allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [4 Aug 2011] Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/20 and Allura CV20
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH