Events

Alerta De Seguridad para Stellaris PC Vision Enhancement System with Integrated Laser

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

¿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
    2014-11-13
  • Fecha de publicación del evento
    2014-11-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141113.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: bausch & lomb stellaris pc vision enhancement system with integrated laser medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning the stellaris pc vision enhancement system with integrated laser. the affected products are as follows: stellaris pc w/ laser: part number bl14304. stellaris pc w/ laser upgrade: part numbers bl1433 (stellaris pc w v3 software) with bl2272 (laser upgrade kit) and bl14334 (stellaris pc w v4 software) with bl2272 (laser upgrade kit). the manufacturer has identified a software anomaly where it can occur that when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo mode to endo continuous mode) and the system is in “standby”, the system will automatically transition to “ready” to fire state. this defeats one of the several safety mechanisms in the device to prevent inadvertent firing of the laser. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 november 2014.

Device

Stellaris PC Vision Enhancement System with Integrated Laser
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bausch & Lomb Stellaris PC Vision Enhancement System with Integrated Laser
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb