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.
FDA Recall Z-2081-2019 · Posted None
Advertisement
Recalling FirmXcision Medical Systems, LLC
Recall StatusTerminated
Product CodeIWB
Date Initiated2019-07-03
Date Terminated2021-07-01
Product Quantity2
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
The products were distributed to the following US states: MD and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement