Device recall
Z-2316-2009: Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare…
FDA device recall · Class II · GE Healthcare Integrated IT Solutions
Key facts
| Recall number (Z-number) | Z-2316-2009 |
|---|---|
| Recall event | 52858 |
| Product | Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images. |
| Product code | LMB |
| Recalling firm | GE Healthcare Integrated IT Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 25, 2011 |
| FEI number | 3004526608 |
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