Class 2 Device Recall RL Sense

• Date Initiated by Firm: September 15, 2010
• Date Posted: January 27, 2011
• Recall Status: Terminated on January 31, 2011
• Recall Number: Z-0970-2011
• Recall Event ID: 57703
• Product: RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night.
• Code Information: Model Proto6, Rev-J Firmware; and Protypes 1-5 Various
• FEI Number: 3008752911
• Recalling Firm/ Manufacturer: Sleep Modus; 3838 Cabana Lane; Dallas TX 75229
• Manufacturer Reason for Recall: Device had no 510(k) clearance prior to patient use.
• FDA Determined Cause: Other
• Action: Sleep Modus, Inc. notified consignees by e-mail on 9/15/2010 and 10/7/2010. The e-mail identified the product, the problem, and the action to be taken. Customers were instructed to let them know if they experienced any of the issues identified in the e-mail. For questions call 214-405-4055.
• Quantity in Commerce: 110 devices (2 per kit)
• Distribution: Nationwide Distribution including Texas

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.