# FDA recall Z-1185-2021

> **Brainlab AG** · Class II · device recall initiated 2021-03-01.

## Product

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

## Reason for recall

In case of a failed automatic marker detection, a software error causes parts of the  display to incorrectly behave as if the current patient position is within predefined tolerances  and may allow the user to proceed to treatment despite potentially exceeding shift values.

## Distribution

USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.

## Key facts

- **Recall number:** Z-1185-2021
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-01
- **Report date:** 2021-03-17
- **Termination date:** 2023-03-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2021

## Citation

> AI Analytics. FDA recall Z-1185-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1185-2021. Source: US FDA. Licensed CC0.

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