Xcision Medical Systems, LLC recalls GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP
Recalled 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.
Hazard / Issue
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Issued by
FDA
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