Device recall
Z-2081-2019: GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product…
FDA device recall · Class II · Xcision Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-2081-2019 |
|---|---|
| Recall event | 83342 |
| Product | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment. |
| Product code | IWB |
| Recalling firm | Xcision Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 1, 2021 |
| 510(k) numbers | K180571 |
| FEI number | 3014273653 |
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