Events

Alerta De Seguridad para Sigma Delta Vaporizer

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

¿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
    2013-04-09
  • Fecha de publicación del evento
    2013-04-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409b.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: penlon sigma delta vaporizer medical device manufacturer, penlon ltd. issued a medical device safety alert concerning penlon sigma delta vaporizer. it has come to the manufacturer’s attention of an instance where the installation and pre-use checks listed in the user manual may not have been followed prior the clinical use of the vaporizer. penlon ltd. has updated the installation and daily pre-use check sections of the user manual to ensure that the instructions are explicit and clear. the manufacturer reminds and requests users to follow the instructions for daily pre-use checks and initial checks and servicing. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.

Device

Sigma Delta Vaporizer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Penlon Sigma Delta Vaporizer
  • Manufacturer
    Penlon Ltd

Manufacturer

Penlon Ltd