CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
AIRO Mobile CT System recalled by Mobius Imaging
Mobius Imaging is recalling AIRO Mobile CT System. The recall was initiated on 1 Aug 2018 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-2991-2018
- FDA event ID
- 80867
- Recalling firm
- Mobius Imaging, Shirley, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2018
- FDA classified
- 14 Sep 2018
- Reported
- 26 Sep 2018
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Aug 2018 | Recall initiated by company | |
| 14 Sep 2018 | Classified by FDA | +44 days |
| 26 Sep 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
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.
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 # MobiCT-32
Where it was distributed
US and foreign distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model # MobiCT-32
Where was it sold?
US and foreign distribution.
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 26 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 | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |