FDA Recall
Terminated
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.
Recall: Z-0970-2011
·
Initiated September 15, 2010
Recall
- Recall Number
- Z-0970-2011
- Event Number
- 57703
- Firm
- Sleep Modus
- FEI Number
- 3008752911
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 15, 2010
- Posted
- January 27, 2011
- Terminated
- January 31, 2011
- Address
- 3838 Cabana Lane, Dallas, TX, 75229
Description
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.
Reason
Device had no 510(k) clearance prior to patient use.
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.
Distribution
Nationwide Distribution including Texas
Quantity
110 devices (2 per kit)