Device recall
Z-0393-06: Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to…
FDA device recall · Class II · Varian Medical Systems Inc
Key facts
| Recall number (Z-number) | Z-0393-06 |
|---|---|
| Recall event | 34160 |
| Product | Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48… |
| Product code | IWB |
| Recalling firm | Varian Medical Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2006 |
| 510(k) numbers | K010975, K023052, K932501 |
| FEI number | 2916710 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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