Food, drugs, devices › Mobius Imaging, LLC
Device recall: Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
FDA enforcement event 69993 is a device recall by Mobius Imaging, LLC of Ayer, MA, initiated 8 Dec 2014 and classified Class II, with 1 product record.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 6 Jul 2015. 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, Ayer, MA.
Reason for recall
"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."
Distribution
"USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1016-2015 | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. | 21 devices distributed. 15 of these devices affected by the software v. 1.1.1+ patch | Class II | Terminated | 4 Feb 2015 |
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 |
| 26 Sep 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomogr | 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: "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."
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: "USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jul 2015. "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.