Drug recall
Medtronic Navigation O-arm 02 surgical x-ray imaging system
FDA recall event 74158 · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Event ID | 74158 |
|---|---|
| Recall numbers | Z-2083-2016 |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Product type | Devices |
| Products | Medtronic Navigation O-arm 02 surgical x-ray imaging system |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be… |
| Initiation date | Mar 17, 2016 |
| Report date | Jul 13, 2016 |
| Termination date | Apr 6, 2021 |
| 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: