Device recall
Z-0501-2013: Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand…
FDA device recall · Class II · Covidien LLC dba Uni-Patch
Key facts
| Recall number (Z-number) | Z-0501-2013 |
|---|---|
| Recall event | 61209 |
| Product | Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation. |
| Product code | GXY |
| Recalling firm | Covidien LLC dba Uni-Patch |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 3, 2013 |
| 510(k) numbers | K902195 |
| FEI number | 1000116809 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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