Device recall
Z-0118-2009: iSite PACS (Picture Archiving and Communication System), software versions…
FDA device recall · Class II · Philips Healthcare Informatics, Inc.
Key facts
| Recall number (Z-number) | Z-0118-2009 |
|---|---|
| Recall event | 49403 |
| Product | iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical… |
| Product code | LLZ |
| Recalling firm | Philips Healthcare Informatics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2010 |
| 510(k) numbers | K042292, K063267 |
| FEI number | 3002971142 |
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