Events

Alerta De Seguridad para SEDASYS Computer-Assisted Personalized Sedation System

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

¿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
    2015-09-07
  • Fecha de publicación del evento
    2015-09-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150907.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: ethicon sedasys computer-assisted personalized sedation system the united states food and drug administration (fda) has issued a medical device safety alert concerning sedasys computer-assisted personalized sedation system [product code: sedpru01], manufactured by ethicon endo-surgery inc. the manufacturer has found that disinfecting methods not specified in the instructions for use (ifu) have led to the degradation of the plastic material of the sedasys system control unit. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website:http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-2374-2015&w=09022015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions posted on 7 september 2015.

Device

SEDASYS Computer-Assisted Personalized Sedation System

Manufacturer

Ethicon Endo-Surgery Inc