Events

Alerta De Seguridad para Ceiling Suspensions SA Models Powerled, Hled, Standop Hanaulux Voltage Series 3000. Suspensions of ceiling manufactured between March 2012 and June 2012.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS..

¿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
  • ID del evento
    1577
  • Fecha
    2015-05-12
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Check additional information in the Alert Message distributed by the company to its customers, available at http://portal.anvisa.gov.br/wps/wcm/connect/c37faa00485cd4f5af0eaf734e60b39c/Seguran%% (On 07/21/2015): affected products were not marketed in Brazil, according to updated information of the company MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA .
  • Causa
    Friction in the double suspensions of the equipment can lead to the detachment of pieces of paint, which may eventually fall into the surgical field of a patient.
  • Acción
    MAQUET will carry out on-the-spot checks on its customers, through its authorized technical specialists, to determine if the suspension arms have friction. If this situation is verified the company will schedule the replacement of the suspensions.

Device

Ceiling Suspensions SA Models Powerled, Hled, Standop Hanaulux Voltage Series 3000. Suspensions o...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS.
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    ANVSANVISA