Alerta De Seguridad para TEXAS Bronchoscope Tube

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

¿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
    2018-09-21
  • Fecha de publicación del evento
    2018-09-21
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: richard wolf gmbh texas bronchoscope tube medical device manufacturer, richard wolf gmbh, has issued a medical device safety alert concerning its texas bronchoscope tube [product numbers: 825200641, 825200841, 825200842, 825201041, 825201241, 825201441, 825210830, 825211230, and 825211430]. the manufacturer became aware of a potential deficiency of its texas bronchoscope tube product. non-functionally relevant bonding points / cemented areas of the affected products may come loose and therefore lead to an extension of the operating time. generally the affected user discovers such separations of fibers of glue during the visible and the function inspection. they are advised to check their stock and return the affected products to the manufacturer for device correction. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 september 2018.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medical Device Safety Alert: Richard Wolf GmbH TEXAS Bronchoscope Tube
  • Manufacturer

Manufacturer