Device recall
Z-1080-2013: Harmonie software versions 5.1 uo to 6.2e: Harmonie-E Long Term Monitoring…
FDA device recall · Class II · Stellate Systems
Key facts
| Recall number (Z-number) | Z-1080-2013 |
|---|---|
| Recall event | 64594 |
| Product | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid… |
| Product code | GWQ |
| Recalling firm | Stellate Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2013 |
| 510(k) numbers | K010728, K083577 |
| FEI number | 3002808695 |
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