Device recall
Z-1643-2015: Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle…
FDA device recall · Class II · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1643-2015 |
|---|---|
| Recall event | 71117 |
| Product | Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may… |
| Product code | MUJ |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2016 |
| 510(k) numbers | K041577 |
| FEI number | 1218950 |
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