Events

Alerta De Seguridad para Motus Laser Therapy Device (Model EA-Cure)

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
    1
  • Fecha
    2018-02-15
  • 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 is not marked with the number of the notified body (does not comply with points 39 and 40 of the regulation); no information on the manufacturer and its address is provided on the label of the medical device or in the instructions for use (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); the name of the model (hdcure max) on the label embedded in the medical device packaging does not match the model name on the label of the medical device (does not meet the requirement of annex 1, paragraph 14.3.2 of the regulation).
  • Acción
    Cancel and remove from the market of the Republic of Lithuania

Device

Motus Laser Therapy Device (Model EA-Cure)

Manufacturer

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