Events

Alerta De Seguridad para s5/s5i Imaging System Software Version 3.2.1/3.2.2

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

¿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
    2012-09-04
  • Fecha de publicación del evento
    2012-09-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120904a.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: volcano s5/s5i imaging system software version 3.2.1/3.2.2 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning volcano s5/s5i imaging system with software version 3.2.1/3.2.2, manufactured by volcano corporation. under very specific and remote conditions, two software display errors may occur in the 3.2.X intravascular ultrasound system (ivus) software when used with digital ivus catheters (except pv .018 and pv 8.2) and the rotational revolution 45 mhz catheter. the software display errors do not occur in the digital ivus catheters if the normal (default) of 10mm field of view (fov) is used and in the revolution catheter if the system default of 8 mm fov is used. if the software errors occur, the display will be shifted to a different fov and will differ from the angiographic data. if the user fails to compare the displayed data to the angiographic data as required by the instructions for use, the issue may be overlooked, leading to a possible error in vessel sizing with a moderate potential for restenosis or the potential placement of an additional stent. the in-line digital measurements, vh ivus, chromaflo and fractional flow reserve measurements are not affected. the manufacturer is developing a software patch to address the errors and will contact their customers for system upgrade. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 4 september 2012.

Device

s5/s5i Imaging System Software Version 3.2.1/3.2.2
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Volcano s5/s5i Imaging System Software Version 3.2.1/3.2.2
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH