Device recall
Z-0456-2009: GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System…
FDA device recall · Class II · GE Healthcare Integrated IT Solutions
Key facts
| Recall number (Z-number) | Z-0456-2009 |
|---|---|
| Recall event | 49460 |
| Product | GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions… |
| Product code | HGM |
| Recalling firm | GE Healthcare Integrated IT Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 3, 2008 |
| 510(k) numbers | K993008 |
| FEI number | 3004526608 |
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