Device recall
Z-1399-06: GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and…
FDA device recall · Class II · Varian Medical Systems
Key facts
| Recall number (Z-number) | Z-1399-06 |
|---|---|
| Recall event | 35717 |
| Product | GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12it radionuclide applicator system. |
| Product code | JAQ |
| Recalling firm | Varian Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2006 |
| 510(k) numbers | K912555 |
| 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