Device recall
Z-2560-2019: Monaco RTP System, 5.40 Unity, radiation treatment planning system Product…
FDA device recall · Class II · Elekta Inc
Key facts
| Recall number (Z-number) | Z-2560-2019 |
|---|---|
| Recall event | 83692 |
| Product | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen… |
| Product code | MUJ |
| Recalling firm | Elekta Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183037 |
| FEI number | 1937649 |
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