# FDA recall Z-1846-2021

> **Brainlab AG** · Class II · device recall initiated 2021-05-14.

## Product

ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

## Reason for recall

Display of potential patient movement might be delayed to the user for high dose treatments.

## Distribution

US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX.  There was no government/military distribution.

## Key facts

- **Recall number:** Z-1846-2021
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-14
- **Report date:** 2021-06-16
- **Termination date:** 2023-03-20

- **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-1846-2021

## Citation

> AI Analytics. FDA recall Z-1846-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1846-2021. Source: US FDA. Licensed CC0.

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