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 | Terminated |
| Reason | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
| 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. |
| Quantity | 2 |
| Distribution | The products were distributed to the following US states: MD and TX. |
| Initiated | 2019-07-03 |
| Classified | 2019-07-25 |
| Terminated | 2021-07-01 |
| Recall number | Z-2081-2019 |
| 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-2081-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83342/
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