Data Foundry

Medical device recalls 2022

MobiCT-32 AIRO Mobile CT Scanner — Class II medical device recall Z-0344-2023

Terminated recall by Mobius Imaging, LLC, reported 2022-12-07, distributed in CO, TN, UT. Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass chargi

Recall numberZ-0344-2023
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMobius Imaging, LLC, Shirley, MA, United States
Recall initiated2022-11-18
Classified2022-11-30
Reported by FDA2022-12-07
Terminated2025-02-26
DistributedCO, TN, UT
Quantity3
UPC / GTIN / UDI-DI00869346000200
Serial numbersAIRO-0124, AIRO-0145, AIRO-0288
Model numbersMOBICT-32

Product

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0344-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.