Device recall
Z-0487-2012: Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models…
FDA device recall · Class II · Stellate Systems
Key facts
| Recall number (Z-number) | Z-0487-2012 |
|---|---|
| Recall event | 56540 |
| Product | Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T)… |
| Product code | GWQ |
| Recalling firm | Stellate Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2011 |
| FEI number | 3002808695 |
At a glance
- None 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