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
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
What You Should Do
Remedy
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.
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Products
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
- Brand
- Xcision Medical Systems, LLC
- UPC
- Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
Units Affected
2