Device recall
Z-0604-2016: Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0604-2016 |
|---|---|
| Recall event | 72869 |
| Product | Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. |
| Product code | MUJ |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2021 |
| 510(k) numbers | K121448 |
| FEI number | 1037831 |
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