# FDA recall Z-0509-2018

> **Brainlab AG** · Class II · device recall initiated 2017-07-28.

## Product

AIRO Mobile CT System, Model Number: MobiCT-32    Product Usage:  The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).

## Reason for recall

Risk of unintended motion while the AIRO system is in transport mode.

## Distribution

Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV;  and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.

## Key facts

- **Recall number:** Z-0509-2018
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-28
- **Report date:** 2018-02-14
- **Termination date:** 2018-07-25

- **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-0509-2018

## Citation

> AI Analytics. FDA recall Z-0509-2018. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0509-2018. Source: US FDA. Licensed CC0.

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