Device recall
Z-0065-2014: VARISOURCE Breast Template System for high-dose rate Brachytherapy…
FDA device recall · Class II · Varian Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0065-2014 |
|---|---|
| Recall event | 66121 |
| Product | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA |
| Product code | JAQ |
| Recalling firm | Varian Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2014 |
| 510(k) numbers | K023220 |
| 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