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

Recalled January 24, 2024 · FDA recall Z-0750-2024 · Xcision Medical Systems

Hazard

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

Units

4 units

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Xcision Medical Systems, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →