Retiro De Equipo (Recall) de Device Recall Beauty Angel

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por JK Products & Services, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Beauty Angel - Product Code 000
  • Causa
    The beauty angel was marketed without a 510k.
  • Acción
    JK Products sent a Mandatory Field Correction Notice - Immediate Action Required letter dated February 10, 2012, to all affected customers. The letter identified the product the problem, and the action to be taken by the customer. The firm instructed customers that they would be replacing the operating instructions for the affected product with new ones that meet the requirements defined by the regulatory authorities. Customers were instructed not to make claims that indicate that using the affected product will result in medical or health benefits, or that directly or indirectly imply that the affected product is intended to cure, treat, diagnose or pevent an illness, or disease. Customers were asked to complete the new owner information request on the return post care enclosed and return to the firm. If product was further distributed those accounts should be contacted immediately and should be advised of this Mandatory Field Correction Notice. For questions customers should call 870-935-1130. For questions regarding this recall call 870-268-2702.


  • Modelo / Serial
    All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201.
  • Distribución
    Worldwide Distribution - USA (nationwide) and Canada
  • Descripción del producto
    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging || For human use.
  • Manufacturer


  • Dirección del fabricante
    JK Products & Services, Inc, 1 Walter Kratz Dr, Jonesboro AR 72401-0609
  • Source