AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be use...

FDA Device Recall #Z-0715-2018 — Class II — September 26, 2017

Recall Summary

Recall Number Z-0715-2018
Classification Class II — Moderate risk
Date Initiated September 26, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mobius Imaging, LLC
Location Shirley, MA
Product Type Devices
Quantity 105

Product Description

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 Pattern

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

Lot / Code Information

Requested.

Other Recalls from Mobius Imaging, LLC

Recall # Classification Product Date
Z-1040-2026 Class II Detachable 10in Pend FRU-1 Pend component for t... Dec 4, 2025
Z-1041-2026 Class II Detachable 10in Pendant Upgrade component for t... Dec 4, 2025
Z-0957-2023 Class II MobiCT-32 AIRO Mobile CT Scanner, Cat. No. Mobi... Dec 7, 2022
Z-0344-2023 Class II MobiCT-32 AIRO Mobile CT Scanner, Cat. No. Mobi... Nov 18, 2022
Z-2991-2018 Class II AIRO Mobile CT System Model # MobiCT-32 Aug 1, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.