Device recall
Z-0594-2012: Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model #…
FDA device recall · Class II · Philips Medical Systems (Cleveland), Inc.
Key facts
| Recall number (Z-number) | Z-0594-2012 |
|---|---|
| Recall event | 60549 |
| Product | Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101… |
| Product code | IYE |
| Recalling firm | Philips Medical Systems (Cleveland), Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2014 |
| 510(k) numbers | K041577 |
| FEI number | 3004022368 |
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