FDA Medical Device Recalls (openFDA)
Xcision Medical Systems, LLC: 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.
- Recall number
- Z-2081-2019
- Recalling firm
- Xcision Medical Systems, LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-07-03
- Posted
- not on file
- Terminated
- 2021-07-01
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent a Field Correction Notice letters dated 7/3/19 to customers. The letter identified the affected product, problem and actions to be taken. If you need any further information or support concerning this issue, please contact Xcsion Customer Support at 855-924-7466.
- Quantity
- 2
- Distribution
- The products were distributed to the following US states: MD and TX.
- Lot, serial or model codes
- Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
- 510(k) numbers
- ["K180571"]
- PMA numbers
- not on file
- Product code
- IWB
- Firm FEI
- 3014273653
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28