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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Xcision Medical Systems, LLC
Lot Codes / Batch Numbers
Serial Numbers GP0002, GP0004, UDI: (01) 00850002615005
Products Sold
Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
Xcision Medical Systems, LLC is recalling GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod due to One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD, TX
Page updated: Jan 10, 2026