# FDA recall Z-0715-2018

> **Mobius Imaging, LLC** · Class II · device recall initiated 2017-09-26.

## 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

If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan.

## Distribution

Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of  Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan

## Key facts

- **Recall number:** Z-0715-2018
- **Recalling firm:** Mobius Imaging, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-26
- **Report date:** 2018-03-07
- **Termination date:** 2018-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shirley, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2018

## Citation

> AI Analytics. FDA recall Z-0715-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0715-2018. Source: US FDA. Licensed CC0.

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