FDA-Device2019-07-31Class II
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.
Xcision Medical Systems, LLC
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.
Sold states
The products were distributed to the following US states: MD and TX.
Affected count
2
Manufactured in
9176 Red Branch Rd, Ste O, Columbia, MD, United States
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 to a partial volume of the breast in conjunction with breast conserving treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2081-2019Don't want to check this manually?
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