Events

Retiro De Equipo (Recall) de Device Recall Fitness Gear Inversion table

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 Dick's Sporting Goods.

¿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
    Recall
  • ID del evento
    70136
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1003-2015
  • Fecha de inicio del evento
    2014-12-29
  • Fecha de publicación del evento
    2015-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132296
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • Causa
    Reports of customers falling from the inversion table and sustaining injuries. the inversion table is a fitness product, not a medical device. dsg removed medical claims from product labels and advertising.
  • Acción
    DSG sent emails and medical device correction notices, dated December 2014, to consumers who made purchases online and retail store consumers for whom DSG has contact information via its Scorecard customer loyalty program. DSG also posted the recall on their web site and notified their retail stores with instructions to post notices in DICKs stores. DSG plans to remind stores approximately monthly for three months to display the recall poster, beginning one month after the recall announcement. Consumers were asked to return the product to the stores where they were purchased for a full refund. A Press Release, dated January 8, 2015, was also issued about the recall.

Device

Device Recall Fitness Gear Inversion table
  • Modelo / Serial
    Style STE00059FG and Style STE00118FG
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.
  • Manufacturer
    Dick's Sporting Goods

Manufacturer

Dick's Sporting Goods
  • Dirección del fabricante
    Dick's Sporting Goods, 345 Court St, Coraopolis PA 15108-3817
  • Empresa matriz del fabricante (2017)
    Dick's Sporting Goods
  • Source
    USFDA