Device recall
Z-1268-06: GammaWin software, part number GM11019110, versions up to and including 1.62…
FDA device recall · Class II · Varian Medical Systems
Key facts
| Recall number (Z-number) | Z-1268-06 |
|---|---|
| Recall event | 35694 |
| Product | GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy. |
| Product code | JAQ |
| Recalling firm | Varian Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2007 |
| 510(k) numbers | K983436 |
| FEI number | 3000206172 |
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