Xcision Medical Systems, LLC recalls GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device…

Recall date

July 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2081-2019

FDA classification

Class II

Brand / firm

Xcision Medical Systems, LLC

Sold / distributed

The products were distributed to the following US states: MD and TX.

Why it was recalled

One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.