Events

Rappel de Device Recall RSFBG Full Back Conductive Garment

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 International Rehabilitative Sciences, Inc..

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
    55578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2093-2010
  • Date de mise en oeuvre de l'événement
    2010-05-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91187
  • 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
    electrode, cutaneous - Product Code GXY
  • Cause
    Device distributed with labeling and ifu outside of their 510(k) clearance.
  • Action
    The firm, RS Medical, mailed "URGENT NOTICE OF VOLUNTARY CORRECTIVE ACTION" letters dated May 14, 2010, to customers on May 17, 2010 and letters to physicians/consignees on May 19, 2010. The letters included an updated RS-FBG Operation Manual and stated what the update covered; i.e. that the device is indicated for use on the "middle and upper back". The customers were ask to please read your new manual and replace your original RS-FBG Full Back Conductive Garment Operation Manual with this updated version and discard your old RS-FBG Garment Operation Manual. RS Medical stated that your RS-FBG Garment is not affected by this Corrective Action, only the Operation Manual. RS Medical informed the customers that you may continue to use the RS-FBG Full Back Garment with your RS Medical Stimulator as prescribed by your healthcare provider. If you have any questions or concerns, please call our Toll Free Customer Service number at 1-866-417-1293, email us at RSFBG@rsmedical.com or visit our special web page at www.rsmedical.com/rsfbginfo.

Device

Device Recall RSFBG Full Back Conductive Garment
  • Modèle / numéro de série
    ************All serial numbers from "GA133809" and lower. Code Breakdown: "GA" specific for Full Back Garments; "133809" is a six digit sequential number as devices are manufactured.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. || The RS-FBG is a prescription device for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments. The device is sold individually in several variations for size. It is fitted to the patient and an RS Medical employee gives the patient instructions on how to utilize the device with proper electrode placement in conjunction with the respective TENS/muscle stimulator.
  • Manufacturer
    International Rehabilitative Sciences, Inc.

Manufacturer

International Rehabilitative Sciences, Inc.