Device recall
Z-0339-2009: TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected…
FDA device recall · Class II · TomoTherapy Incorporated
Key facts
| Recall number (Z-number) | Z-0339-2009 |
|---|---|
| Recall event | 49607 |
| Product | TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy. |
| Product code | IYE |
| Recalling firm | TomoTherapy Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2011 |
| 510(k) numbers | K060912 |
| 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