FDA
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.
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
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.