Events

Alerta De Seguridad para Syngo X-Workplace with software version VD10E

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

¿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
    2016-03-16
  • Fecha de publicación del evento
    2016-03-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160316.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: siemens syngo x-workplace with software version vd10e the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning syngo x-workplace with software version vd10e, manufactured by siemens. [catalogue numbers: 10094165, 10281299 and 10502522 when used in combination with carto systems]. according to the manufacturer, an issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and cannot be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation. the manufacturer is advising users that a software upgrade will be performed as a permanent correction. users are advised to stop using any segmentation result for export to the carto system until the software upgrade is performed. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00267-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 16 march 2016.

Device

Syngo X-Workplace with software version VD10E
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Siemens Syngo X-Workplace with software version VD10E
  • Manufacturer
    Siemens.

Manufacturer

Siemens.