Device recall
Z-0836-2009: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE…
FDA device recall · Class II · GE Healthcare Integrated IT Solutions
Key facts
| Recall number (Z-number) | Z-0836-2009 |
|---|---|
| Recall event | 50538 |
| Product | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also… |
| Product code | LLZ |
| Recalling firm | GE Healthcare Integrated IT Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2010 |
| 510(k) numbers | K043415 |
| FEI number | 3004526608 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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