# FDA recall Z-2991-2018

> **Mobius Imaging, LLC** · Class II · device recall initiated 2018-08-01.

## Product

AIRO Mobile CT System  Model # MobiCT-32

## Reason for recall

The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.

## Distribution

US  and foreign distribution.

## Key facts

- **Recall number:** Z-2991-2018
- **Recalling firm:** Mobius Imaging, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2018-09-26
- **Termination date:** 2019-12-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2991-2018

## Citation

> AI Analytics. FDA recall Z-2991-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2991-2018. Source: US FDA. Licensed CC0.

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