CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
AIRO Mobile CT System recalled by Mobius Imaging
Mobius Imaging is recalling AIRO Mobile CT System, distributed nationwide in the US. The recall was initiated on 26 Sep 2017 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-0715-2018
- FDA event ID
- 79159
- Recalling firm
- Mobius Imaging, Shirley, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2017
- FDA classified
- 23 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 26 Sep 2017 | Recall initiated by company | |
| 23 Feb 2018 | Classified by FDA | +150 days |
| 7 Mar 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
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, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNew YorkOhioOregonPennsylvaniaRhode Island
Questions about this recall
Is AIRO Mobile CT System recalled?
Yes. Mobius Imaging recalled AIRO Mobile CT System on 26 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0715-2018.
Why was it recalled?
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.
Which lots are affected?
Requested.
Where was it sold?
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, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan
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.
More recalls from Mobius Imaging
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Detachable Pendant Upgrade component recalled by Mobius Imaging | Mobius Imaging | Other | Nationwide |
| Device | CLASS II | Detachable Pend Fru-1 Pend component recalled by Mobius Imaging | Mobius Imaging | Other | Nationwide |
| Device | CLASS II | MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging | Mobius Imaging | Other | Nationwide |
| Device | CLASS II | MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | CO, TN, UT |
| Device | CLASS II | AIRO Mobile CT System recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | MA |
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