Device recall
Z-1881-2011: iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-1881-2011 |
|---|---|
| Recall event | 58044 |
| Product | iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including… |
| Product code | LLC |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2011 |
| 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
- 1–9 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