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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.

FDA Recall Z-0970-2011 · Posted 2011-01-27

Recalling FirmSleep Modus
Recall StatusTerminated
Date Initiated2010-09-15
Date Terminated2011-01-31
Product Quantity110 devices (2 per kit)

Reason for Recall

Device had no 510(k) clearance prior to patient use.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution including Texas

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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