CLASS II Device recall · Reported 4 Feb 2015 · FDA Enforcement Report
Airo Mobile Intraoperative CT I Airo recalled by Mobius Imaging
Mobius Imaging is recalling Airo Mobile Intraoperative CT I Airo, distributed nationwide in the US. The recall was initiated on 8 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1016-2015
- FDA event ID
- 69993
- Recalling firm
- Mobius Imaging, Ayer, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2014
- FDA classified
- 27 Jan 2015
- Reported
- 4 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Dec 2014 | Recall initiated by company | |
| 27 Jan 2015 | Classified by FDA | +50 days |
| 4 Feb 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Where it was distributed
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
Nationwide AlaskaCaliforniaIllinoisMassachusettsNorth CarolinaNew YorkPennsylvaniaTexasWashingtonWest Virginia
Questions about this recall
Is Airo Mobile Intraoperative CT I Airo recalled?
Yes. Mobius Imaging recalled Airo Mobile Intraoperative CT I Airo on 8 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1016-2015.
Why was it recalled?
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.
Which lots are affected?
Serial #s: 2251 (#1)*, 2324 (#2), 2328(#3), 2344 (#4), 2346 (#5), AIRO-0106, AIRO-0107*, AIRO-0108, AIRO-0110, AIRO-0111, AIRO-0112, AIRO-0113, AIRO-0114, AIRO-0115, AIRO-0116, AIRO-0117, AIRO-0118, AIRO-0119, AIRO-0120, AIRO-0122, and AIRO-0123. *Demo system
Where was it sold?
USA including AK, IL, WA, MA, NY, WV, NC, TX, CA, PA and Internationally to Germany, Netherlands, Belgium, Switzerland, Saudi Arabia, Egypt.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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