Events

Alerta De Seguridad para multidiagnost eleva fd

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
    2015-01-21
  • Fecha de publicación del evento
    2015-01-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150121a.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
    Medical device safety alert: philips healthcare multidiagnost eleva fd medical device manufacturer, philips healthcare, has issued a field safety notice concerning multidiagnost eleva fd [product code: 708037]. in the md eleva system, software license keys are used to enable particular functionality. the manufacturer has discovered that in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: the license key for spectral filter the license key for full table tilt range if the license key for spectral filter is not loaded, then a higher than expected patient dose will occur in low dose mode for positioning of the patient, positioning of the x-ray beam, and/or in situations in which the x-ray image has lots of contrast. if the license key for full table tilt range is not loaded, then the table tilt range will be restricted. in such a case not all desired image projections are possible. the manufacturer will perform software upgrade for affected units before may 2015. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 january 2015.

Device

multidiagnost eleva fd
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Healthcare MultiDiagnost Eleva FD
  • Manufacturer
    Philips Healthcare

Manufacturer

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