Events

Alerta De Seguridad para Pneumatic massage machine

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
    4
  • Fecha
    2018-11-23
  • 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 pneumatic massage apparatus and its packaging shall not bear the ce conformity marking and the identification number of the notified body, which does not comply with the requirements of paragraphs 38, 39 and 40 of the regulation; all information on the pneumatic massage apparatus, its packaging and instructions for use is provided in a language other than the european community, which does not comply with the provisions of article 4 (4) of council directive 93/42 / eec; the manufacturer's trade name is indicated on the medical device but does not include the address and the manufacturer's authorized representative in the european economic area, which does not comply with the requirements of annex 1, paragraph 14.3.1 of the regulation.
  • Acción
    Do not allow to enter the Lithuanian market

Device

Pneumatic massage machine

Manufacturer

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