Alerta De Seguridad para ShoulderFlex massager

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por N/A.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Press release
  • Causa
    Safety alert on shoulderflex massager after assessing a medical device safety alert issued by the us food and drug administration (fda) on a personal massager with the brand name “shoulderflex” distributed in the us by a company called king international, the department of health (dh) urges the local community to stop using it because of its association with strangulation or other severe injuries. a dh spokesman remarks that the shoulderflex massager is designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface. "through the department's medical device surveillance scheme, we learnt that there were a few reports of either death or near-strangulation associated with shoulderflex massager in the us.  according to the information available, the incidents were likely to occur when hair, clothing or jewelry became caught in the device, especially those pieces which rotated during use," the spokesman explains. the spokesman states that the department is very concerned as the health risks could be serious even if not fatal.   "thus, in spite of the facts that the devices were mainly sold at stores or online in the us and not known to be on sale here in hong kong, nor has dh received any related notification, given the amount of travelling between the two places and also the popularity of internet trading, we consider it necessary to inform our public of the news and also advise for immediate suspension for the occasional owners," the spokesman deliberates. finally, the spokesman adds that to be prudent, disposal of the device by owners should be in pieces so as to avoid use after reassembling. ends.


  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Press release: Safety alert on ShoulderFlex massager
  • Manufacturer


  • Source