Food, drugs, devices › Mobius Imaging, LLC
Device recall: AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomogr
Mobius Imaging, LLC (Shirley, MA) initiated this device recall on 26 Sep 2017; FDA lists 1 product record under event 79159, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 16 Aug 2018. Initiation: voluntary: firm initiated. Mobius Imaging, LLC has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mobius Imaging, LLC, Shirley, MA.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 patients and patients weighing over 400 lbs. (182 kg). | 105 | Class II | Terminated | 7 Mar 2018 |
Context
Other enforcement events for Mobius Imaging, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Dec 2025 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. | Device | Class II | 2 |
| 7 Dec 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. | Device | Class II | 1 |
| 18 Nov 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 | Device | Class II | 1 |
| 1 Aug 2018 | AIRO Mobile CT System Model # MobiCT-32 | Device | Class II | 1 |
| 8 Dec 2014 | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. | Device | Class II | 1 |
All 6 events for Mobius Imaging, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Aug 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.