Events

Recall of RL Sense

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sleep Modus.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0970-2011
  • Event Initiated Date
    2010-09-15
  • Event Date Posted
    2011-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97049
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • 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.

Device

RL Sense
  • Model / Serial
    Model Proto6, Rev-J Firmware; and Protypes 1-5 Various
  • Distribution
    Nationwide Distribution including Texas
  • Product 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.
  • Manufacturer
    Sleep Modus

Manufacturer

Sleep Modus
  • Manufacturer Address
    Sleep Modus, 3838 Cabana Lane, Dallas TX 75229
  • Manufacturer Parent Company (2017)
    Sleep Modus Inc.
  • Source
    USFDA