Events

Alerta De Seguridad para Navigation System II-Cart and Articulated Arm Camera

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Stryker Instruments and Stryker Leibinger GmbH & Co. KG.

¿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
    2015-05-19
  • Fecha de publicación del evento
    2015-05-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150519.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: stryker navigation system ii-cart and articulated arm camera medical device manufacturer, stryker instruments and stryker leibinger gmbh & co. kg, has issued a field safety notice concerning navigation system ii-cart and articulated arm camera, with the following details: navigation system ii-cart: product code 7700-100-000 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera: product code 7700-103-001 distributed from 23 dec 2011 to 3 aug 2012 articulated arm camera (refurbished): product code 7700-103-001u distributed from 23 dec 2011 to 3 aug 2012 according to the manufacturer, there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in failure of the arm joint. a failure in the weld joint could result in interruption or discontinued use of the navigation system. the manufacturer will perform inspection to all affected systems. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2015.

Device

Navigation System II-Cart and Articulated Arm Camera

Manufacturer

Stryker Instruments and Stryker Leibinger GmbH & Co. KG
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DH