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Mobius Imaging Recalls
7 recalls on record · February 4, 2015 to January 21, 2026 · Medical Devices
Recalls by year
15
18
22
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 21, 2026Medical DevicesFDA
Mobius Imaging, LLC recalls Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Hazard: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
January 21, 2026Medical DevicesFDA
Mobius Imaging, LLC recalls Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Hazard: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
January 25, 2023Medical DevicesFDA
Mobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Hazard: 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.
December 7, 2022Medical DevicesFDA
Mobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Hazard: 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.
September 26, 2018Medical DevicesFDA
Mobius Imaging, LLC recalls AIRO Mobile CT System Model # MobiCT-32
Hazard: 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.
March 7, 2018Medical DevicesFDA
Mobius Imaging, LLC recalls AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed to
Hazard: 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.
February 4, 2015Medical DevicesFDA
Mobius Imaging, LLC recalls Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Hazard: There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation data or incorrect navigation data being transferred to the curve.