# FDA recall Z-0733-2022

> **Brainlab AG** · Class II · device recall initiated 2022-02-25.

## Product

ExacTrac Dynamic software model numbers:    20910-01, ETD Positioning and Moni. 1.0.0 INST;  20910-01A, ETD Positioning and Moni. 1.0.1 INST;  20910-01B, ETD Positioning and Moni. 1.0.2 INST; and   20910-01C ETD Positioning and Moni. 1.0.3 INST.

## Reason for recall

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

## Distribution

Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA.  There was no government or military distribution.  Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0733-2022
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-25
- **Report date:** 2022-03-16

- **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-0733-2022

## Citation

> AI Analytics. FDA recall Z-0733-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0733-2022. Source: US FDA. Licensed CC0.

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