Alerta De Seguridad para STAR Excimer Laser System

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: abbott medical optics star excimer laser system medical device manufacturer, abbott medical optics (amo) ltd, has issued a field safety notice concerning amo star excimer laser system. the affected models are s2, s3, s4 and s4 ir. amo is providing an advisory notice to all customers who use the affected products to make aware of an issue that has the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to a specific component found in a limited amount of star systems. if the system is found to have the component, amo will replace a printed circuit board in the laser at the next service visit. in the unlikely event that the star system loses both oblique and ring illumination, users are advised to contact the manufacturer for assistance. in addition, amo recommends users to use the lowest level of illumination required during the patient treatment in order to reduce high use conditions caused by the oblique and ring illumination lamps being on simultaneously. it is recommended that only two oblique lamps be used (not activating the optional third oblique lamp) in order to further reduce the remote possibility of complete illumination loss. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 september 2013.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Medical Optics STAR Excimer Laser System
  • Manufacturer