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Xcision Medical Systems, LLC recalls GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy de
Recalled July 31, 2019 · FDA recall Z-2081-2019 · Xcision Medical Systems
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. · FDA Class II
Units
2
Sold at
The products were distributed to the following US states: MD and TX.
Description
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
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.
Manufacturer(s)
Xcision Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →