Device recall
Z-0117-2009: Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity…
FDA device recall · Class II · Varian Medical Systems Oncology Systems
Key facts
| Recall number (Z-number) | Z-0117-2009 |
|---|---|
| Recall event | 49399 |
| Product | Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation… |
| Product code | IYE |
| Recalling firm | Varian Medical Systems Oncology Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2010 |
| 510(k) numbers | K033339, K904364 |
| 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