FDA Device recall Z-2081-2019
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in…
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in… by Xcision Medical Systems, citing one bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2081-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-03 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Xcision Medical Systems |
| Distribution | MD, TX |
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
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Identifiers
| code_info | Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2081-2019%22
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