FDA Medical Device Recalls (openFDA)
Sleep Modus: 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 number
- Z-0970-2011
- Recalling firm
- Sleep Modus
- 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.
- Status
- Terminated
- Initiated
- 2010-09-15
- Posted
- 2011-01-27
- Terminated
- 2011-01-31
- Reason
- Device had no 510(k) clearance prior to patient use.
- Root 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
- 110 devices (2 per kit)
- Distribution
- Nationwide Distribution including Texas
- Lot, serial or model codes
- Model Proto6, Rev-J Firmware; and Protypes 1-5 Various
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3008752911
- Firm city
- Dallas
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28