Device recall
Z-2564-2011: Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used…
FDA device recall · Class II · Computerized Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-2564-2011 |
|---|---|
| Recall event | 58258 |
| Product | Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. |
| Product code | MUJ |
| Recalling firm | Computerized Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2014 |
| 510(k) numbers | K071938, K091179 |
| 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