Recall Z-2093-2010 ยท GXY Electrode, Cutaneous
International Rehabilitative Sciences, Inc.
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
| Date | May 17, 2010 |
| Status | Terminated |
| Reason | Device distributed with labeling and IFU outside of their 510(k) clearance. |
| Root cause | 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-F |
| Quantity | 108134 units, 81,939 subject to recall |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090951 | RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDUCTIVE GARMENT , MODEL RS-FBG Rs Medical, Jun 5, 2009 |