Device recall
Z-1394-2010: GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions…
FDA device recall · Class II · Ge Healthcare It
Key facts
| Recall number (Z-number) | Z-1394-2010 |
|---|---|
| Recall event | 55040 |
| Product | GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed… |
| Product code | LLZ |
| Recalling firm | Ge Healthcare It |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2016 |
| 510(k) numbers | K082318 |
| 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