Events

Alerta De Seguridad para Ultrasonic Probe Type Ultrasound Scanner

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por MP Manufacturer Unknown Sender SonoStar Technological Co., Ltd., China.

¿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
    2016-02-26
  • 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
    1. there is no information necessary to identify the medical device and the contents of the packaging (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.2). 2. the ce marking and the number of the notified body shall not be affixed to the medical device or to the packaging of the medical device (not in accordance with mn 4: 2009 38, 39 and 40). 3. there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area (not in compliance with mn 4: 2009, annex 1, clause 14.3.1). 4. no model, batch / serial number (does not meet mn 4: 2009 requirements 14.3.4). 5. no information is available on the safe and proper use of the medical device (not in accordance with mn 4: 2009 annex 1, clause 14.1).
  • Acción
    Disallowed to market

Device

Ultrasonic Probe Type Ultrasound Scanner

Manufacturer

MP Manufacturer Unknown Sender SonoStar Technological Co., Ltd., China
  • Representante del fabricante
    JSC "Hisas"
  • Source
    MH