Xcision Medical Systems, LLC recalls GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended…

Recall date

November 30, 2023

Source

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

Recall number

Z-0750-2024

FDA classification

Class II

Brand / firm

Xcision Medical Systems, LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.

Why it was recalled

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

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 - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 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.