Drug recall
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version…
FDA recall event 91178 · Class II · Mobius Imaging, LLC
Key facts
| Event ID | 91178 |
|---|---|
| Recall numbers | Z-0344-2023 |
| Recalling firm | Mobius Imaging, LLC |
| Product type | Devices |
| Products | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 18, 2022 |
| Report date | Dec 7, 2022 |
| Termination date | Feb 26, 2025 |
| City | Shirley |
| State | MA |
| Country | United States |
| FEI number | 3010151377 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: