CLASS II Device recall · Reported 7 Dec 2022 · FDA Enforcement Report
MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging
Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner, distributed in Colorado, Tennessee, Utah. The recall was initiated on 18 Nov 2022 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-0344-2023
- FDA event ID
- 91178
- Recalling firm
- Mobius Imaging, Shirley, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2022
- FDA classified
- 30 Nov 2022
- Reported
- 7 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 18 Nov 2022 | Recall initiated by company | |
| 30 Nov 2022 | Classified by FDA | +12 days |
| 7 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.
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
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Where it was distributed
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
Questions about this recall
Is MobiCT-32 AIRO Mobile CT Scanner recalled?
Yes. Mobius Imaging recalled MobiCT-32 AIRO Mobile CT Scanner on 18 Nov 2022. The recall is Class II and its status is Terminated. Recall number Z-0344-2023.
Why was it recalled?
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.
Which lots are affected?
UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288
Where was it sold?
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
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 | AIRO Mobile CT System recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | MA |
| Device | CLASS II | AIRO Mobile CT System recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | Nationwide |
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