Device recall
Z-0970-2011: RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of…
FDA device recall · Class II · Sleep Modus
Key facts
| Recall number (Z-number) | Z-0970-2011 |
|---|---|
| Recall event | 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… |
| Recalling firm | Sleep Modus |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2011 |
| FEI number | 3008752911 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database