Events

Rappel de Device Recall Fitness Gear Inversion table

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Dick's Sporting Goods.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70136
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1003-2015
  • Date de mise en oeuvre de l'événement
    2014-12-29
  • Date de publication de l'événement
    2015-01-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132296
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Apparatus, traction, non-powered - Product Code HST
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Style STE00059FG and Style STE00118FG
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    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
  • Adresse du fabricant
    Dick's Sporting Goods, 345 Court St, Coraopolis PA 15108-3817
  • Société-mère du fabricant (2017)
    Dick's Sporting Goods
  • Source
    USFDA