Device recall
Z-2581-2014: Monaco The Monaco system is used to make treatment plans for patients with…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-2581-2014 |
|---|---|
| Recall event | 68985 |
| Product | Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside… |
| Product code | MUJ |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2021 |
| 510(k) numbers | K132971 |
| 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