Device recall
Z-0814-2011: ThomoTherapy Hi-Art System Intended to be used as an integrated system for the…
FDA device recall · Class II · TomoTherapy Incorporated
Key facts
| Recall number (Z-number) | Z-0814-2011 |
|---|---|
| Recall event | 57337 |
| Product | ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. |
| Product code | MUJ |
| Recalling firm | TomoTherapy Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2012 |
| 510(k) numbers | K082005 |
| FEI number | 3003873069 |
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