# FDA recall Z-1259-2023

> **Brainlab AG** · Class II · device recall initiated 2023-02-14.

## Product

Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

## Reason for recall

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

## Distribution

US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA.  There was no government/military distribution.

## Key facts

- **Recall number:** Z-1259-2023
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-14
- **Report date:** 2023-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1259-2023

## Citation

> AI Analytics. FDA recall Z-1259-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1259-2023. Source: US FDA. Licensed CC0.

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