Device recall
Z-1023-2011: Radiation therapy device. Medical charged particle radiation therapy system with…
FDA device recall · Class II · Accuray Inc
Key facts
| Recall number (Z-number) | Z-1023-2011 |
|---|---|
| Recall event | 54658 |
| Product | Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors… |
| Product code | MUJ |
| Recalling firm | Accuray Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2011 |
| 510(k) numbers | K091146 |
| FEI number | 1000123585 |
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