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U.S. Department of Health and Human Services

Class 2 Device Recall RSFBG Full Back Conductive Garment

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  Class 2 Device Recall RSFBG Full Back Conductive Garment see related information
Date Initiated by Firm May 17, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on August 15, 2012
Recall Number Z-2093-2010
Recall Event ID 55578
510(K)Number K090951  
Product Classification electrode, cutaneous - Product Code GXY
Product 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.
Code Information ************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.
Recalling Firm/
Manufacturer		 International Rehabilitative Sciences, Inc.
14001 Se 1st St
Vancouver WA 98684-3503
For Additional Information Contact Timothy J. Johnson
360-892-0339
Manufacturer Reason
for Recall		 Device distributed with labeling and IFU outside of their 510(k) clearance.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 108134 units, 81,939 subject to recall
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXY and Original Applicant = RS MEDICAL
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