Device recall
Z-2645-2011: ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3…
FDA device recall · Class II · Computerized Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-2645-2011 |
|---|---|
| Recall event | 58206 |
| Product | ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is… |
| Product code | MUJ |
| Recalling firm | Computerized Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2014 |
| 510(k) numbers | K080601 |
| 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