Device recall
Z-0050-2018: Oncentra Brachy 4.5 radiation therapy software The firm name on the label is…
FDA device recall · Class II · Nucletron BV
Key facts
| Recall number (Z-number) | Z-0050-2018 |
|---|---|
| Recall event | 78087 |
| Product | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates… |
| Product code | MUJ |
| Recalling firm | Nucletron BV |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| 510(k) numbers | K132816 |
| FEI number | 3002807741 |
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