Shirley, MA, United States
Mobius Imaging, LLC recalls
5 recalls recorded since 2018, most recently on 4 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 December 2025
- Reason
- AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Distribution
- US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1040-2026, Z-1041-2026
- Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
- Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Ongoing Class II Medical devices
- Recall started
- 7 December 2022
- Reason
- Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Chinese Taipei, Denmark, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Malaysia, Mexico, Morocco, Nepal, Nethe
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0957-2023
- MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Terminated Class II Medical devices
- Recall started
- 18 November 2022
- Terminated
- 26 February 2025
- Reason
- Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.
- Distribution
- Domestic distribution to consignees in Colorado, Tennessee, and Utah.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0344-2023
- MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Terminated Class II Medical devices
- Recall started
- 1 August 2018
- Terminated
- 13 December 2019
- Reason
- 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.
- Initiated
- FDA Mandated
- Recall number
- Z-2991-2018
- AIRO Mobile CT System Model # MobiCT-32
Terminated Class II Medical devices
- Recall started
- 26 September 2017
- Terminated
- 16 August 2018
- Reason
- 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, Ne
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0715-2018
- 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 patie
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.