Events

Alerta De Seguridad para Cushion CYSM-289

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Not specified.

¿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
  • Número del evento
    8
  • Fecha
    2018-11-30
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 recall data from the U.S. and Lithuania.
  • Notas adicionales en la data
  • Causa
    The medical device and its packaging do not bear the ce conformity marking and the identification number of the notified body, which does not comply with the requirements of articles 38, 39 and 40 of the regulation; there is no label on the medical device, which is not in accordance with annex 14.1 of the regulation. requirements; the name of the manufacturer, its address and the manufacturer's authorized representative in the european economic area are not specified, which does not comply with the requirements of annex 1, paragraph 14.3.1. the batch / serial number is not specified, which does not meet the requirements of annex 1, paragraph 14.3.4 of the regulation.
  • Acción
    Do not allow to enter the Lithuanian market

Device

Cushion CYSM-289

Manufacturer

Not specified
  • Representante del fabricante
    UAB Urmo Group
  • Source
    MH