Device recall
Z-0304-2007: 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle…
FDA device recall · Class II · Varian Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0304-2007 |
|---|---|
| Recall event | 36556 |
| Product | 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190. |
| Product code | IYE |
| Recalling firm | Varian Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2008 |
| 510(k) numbers | K001643, K050479 |
| 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