Drug recall
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and…
FDA recall event 92778 · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Event ID | 92778 |
|---|---|
| Recall numbers | Z-2449-2023 |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Product type | Devices |
| Products | The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ground cable installed incorrectly. |
| Initiation date | Jul 25, 2023 |
| Report date | Aug 30, 2023 |
| City | Littleton |
| State | MA |
| Country | United States |
| FEI number | 3004785967 |
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: