GammaPod Stereotactic Radiotherapy System Model A — Class II medical device recall Z-2081-2019
Terminated recall by Xcision Medical Systems, LLC, reported 2019-07-31, distributed in MD, TX. One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in
| Recall number | Z-2081-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xcision Medical Systems, LLC, Columbia, MD, United States |
| Recall initiated | 2019-07-03 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-07-01 |
| Distributed | MD, TX |
| Quantity | 2 |
| UPC / GTIN / UDI-DI | 00850002615005 |
| Serial numbers | GP0002, GP0004 |
| Model numbers | XMSGP030A00-0.02 |
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.
Reason for recall
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
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-2081-2019. 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.