Events

Alerta De Seguridad para Endeavor Light System

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

¿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
    2013-12-30
  • Fecha de publicación del evento
    2013-12-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131230.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: orascoptic endeavor light system medical device manufacturer, orascoptic, has issued a medical device safety alert concerning its endeavour light system [part no.: 910114-x; serial no.: 78100100 to 78113815]. the manufacturer is informing end users of a possible light output issue with the endeavour light system, which was shipped to place of distribution from november 2011 through august 2013. the manufacturer discovered that intermittent to no light output may occur without proper placement of the spiral temple clip that was provided with the initial purchase. this clip is a critical component of the endeavour light system that should be used to secure the cable to the temple arm of the frame. as a preventive measure, a complimentary spiral temple clip is offered to end users along with instructions on how to place the clip as a means to secure the cable to the temple arm of his/her loupes and prevent strain on the cable that allows power to reach the headlight led. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 december 2013.

Device

Endeavor Light System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Orascoptic Endeavor Light System
  • Manufacturer
    Orascoptic

Manufacturer

Orascoptic