medical Class II Updated 2019-07-31

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

Affected States: MD, TX
Lot/Code Info: Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
View official government recall

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