# FDA recall Z-2081-2019

> **Xcision Medical Systems, LLC** · Class II · device recall initiated 2019-07-03.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2081-2019
- **Recalling firm:** Xcision Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-03
- **Report date:** 2019-07-31
- **Termination date:** 2021-07-01

- **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-2081-2019

## Citation

> AI Analytics. FDA recall Z-2081-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2081-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*