# FDA recall Z-0750-2024

> **Xcision Medical Systems, LLC** · Class II · device recall initiated 2023-11-30.

## 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

- **Recall number:** Z-0750-2024
- **Recalling firm:** Xcision Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-30
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbia, MD, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0750-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0750-2024. Source: US FDA. Licensed CC0.

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