Device recall
Z-1649-2011: TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an…
FDA device recall · Class II · TomoTherapy Incorporated
Key facts
| Recall number (Z-number) | Z-1649-2011 |
|---|---|
| Recall event | 57914 |
| Product | TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues. |
| Product code | MUJ |
| Recalling firm | TomoTherapy Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2014 |
| 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