Events

Alerta De Seguridad para STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30

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

¿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
    2011-07-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110720.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
    Advisory notice: abbott medical optics (amo) star s4 ir excimer laser system software, versions 5.00 through 5.22 and versions 5.00 through 5.30 abbott medical optics (amo) has issued an advisory notice to customers of amo star s4 ir excimer laser system and customers of amo wavescan wavefront system regarding a defect of the iris registration (ir) software on the star s4 ir excimer laser system, versions 5.00 through 5.22 and versions 5.00 through 5.30 respectively. there is a malfunction of the compensation for pupil centroid shift in the affected software versions, which may lead to visual disturbances or reduced best corrected visual acuity. according to the local supplier, the affected products are available in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [20 Jul 2011] Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
  • Manufacturer
    Abbott Medical Optics (AMO)

Manufacturer

Abbott Medical Optics (AMO)