GammaPod — Class II medical device recall Z-0750-2024
Ongoing recall by Xcision Medical Systems, LLC, reported 2024-01-24, distributed nationwide. Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a
| Recall number | Z-0750-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xcision Medical Systems, LLC, Columbia, MD, United States |
| Recall initiated | 2023-11-30 |
| Classified | 2024-01-18 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00850002615005, 00850002615029 |
| Model numbers | XMSGP030A09.07-0.01 |
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.
Reason for recall
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0750-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.