FDA recall Z-0750-2024

Xcision Medical Systems, LLC · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-11-30
Report date: 2024-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0750-2024