Device recall
Z-0932-2011: 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17…
FDA device recall · Class II · Varian Medical Systems, Inc. Oncology Systems
Key facts
| Recall number (Z-number) | Z-0932-2011 |
|---|---|
| Recall event | 57527 |
| Product | 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Varian Medial Systems, Palo Alto, CA Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2011 |
| 510(k) numbers | K081036 |
| FEI number | 2916710 |
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