Device recall
Z-0750-2024: GammaPod - Treatment Planning System-a component of the GammaPod Irradiation…
FDA device recall · Class II · Xcision Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0750-2024 |
|---|---|
| Recall event | 93684 |
| Product | GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 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 | Open, Classified |
| 510(k) numbers | K172706, 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