Drug recall
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
FDA recall event 74153 · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Event ID | 74153 |
|---|---|
| Recall numbers | Z-2082-2016 |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Product type | Devices |
| Products | Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure. |
| 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: