Class II — Xcision Medical Systems, LLC
| Recalling firm | Xcision Medical Systems |
|---|---|
| Registered facility | XCISION MEDICAL SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected |
| 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. |
| Quantity | 4 units |
| Distribution | Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy. |
| Initiated | 2023-11-30 |
| Classified | 2024-01-18 |
| Recall number | Z-0750-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Xcision Medical Systems, LLC (Z-0750-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93684/
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