Drug recall
AIRO Mobile CT System Model # MobiCT-32
FDA recall event 80867 · Class II · Mobius Imaging, LLC
Key facts
| Event ID | 80867 |
|---|---|
| Recall numbers | Z-2991-2018 |
| Recalling firm | Mobius Imaging, LLC |
| Product type | Devices |
| Products | AIRO Mobile CT System Model # MobiCT-32 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| 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… |
| Initiation date | Aug 1, 2018 |
| Report date | Sep 26, 2018 |
| Termination date | Dec 13, 2019 |
| 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: