Events

Alerta De Seguridad para HypoMon Alarm Systems

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por AIMEDICS Pty 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
    2013-08-05
  • Fecha de publicación del evento
    2013-08-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130805.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: aimedics hypomon alarm systems the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning hypomon alarm systems manufactured by aimedics pty ltd. all serial number produced in 2012 and 2013 are affected. the hypomon is not detecting hypoglycemic events at the required levels as indicated in the instructions for use. the manufacturer is requesting customers return the affected products. for details, please visit the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00755-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 august 2013.

Device

HypoMon Alarm Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: AIMEDICS HypoMon Alarm Systems
  • Manufacturer
    AIMEDICS Pty Ltd

Manufacturer

AIMEDICS Pty Ltd
  • Empresa matriz del fabricante (2017)
    AiMedics
  • Source
    DH