Events

Recall of Device Recall RSFBG Full Back Conductive Garment

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Rehabilitative Sciences, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55578
  • Event Risk Class
    Class 2
  • Event Number
    Z-2093-2010
  • Event Initiated Date
    2010-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91187
  • Notes / Alerts
    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.
  • Extra notes in the data
    electrode, cutaneous - Product Code GXY
  • Reason
    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
  • Model / Serial
    ************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.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    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.