Device recall
Z-0323-2011: The device is labeled in part: " RS Medical RS-4i Stimulator". The device is…
FDA device recall · Class II · International Rehabilitative Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-0323-2011 |
|---|---|
| Recall event | 55655 |
| Product | The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return mail bag, and the operation manual. This device is used with cables and… |
| Product code | IPF |
| Recalling firm | International Rehabilitative Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2012 |
| 510(k) numbers | K032652 |
| FEI number | 1000117825 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
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