Recall archive / FDA device enforcement
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 — FDA record Z-0344-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Mobius Imaging, LLC
- Quantity
- 3
- Agency-reported status
- Terminated
- Source record identifier
- Z-0344-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to consignees in Colorado, Tennessee, and Utah.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 7, 2022
- Recall initiation date
- Nov 18, 2022
- Center classification date
- Nov 30, 2022
- Termination date
- Feb 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.