Events

Alerta De Seguridad para VersaCut Tissue Morcellator

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

¿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
    2013-02-25
  • Fecha de publicación del evento
    2013-02-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130225a.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: lumenis versacut tissue morcellator the united states food and drug administration (fda) has issued a medical device safety alert concerning lumenis versacut tissue morcellator manufactured by lumenis limited. the affected model numbers are 0637-245-01 (starter kit) and 0636-470-01 (control box) which includes all products since initial product release in 1998. lumenis is recalling certain models of versacut morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product- tabs.Cfm?action=select&recall_number=z-0795-2013&w=02202013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 february 2013.

Device

VersaCut Tissue Morcellator

Manufacturer

Lumenis Limited