Drug recall
OEC 9800. MDL Numbers: D222250, D141598
FDA recall event 76074 · Class II · GE OEC Medical Systems, Inc
Key facts
| Event ID | 76074 |
|---|---|
| Recall numbers | Z-1059-2017, Z-1060-2017 |
| Recalling firm | GE OEC Medical Systems, Inc |
| Product type | Devices |
| Products | OEC 9800. MDL Numbers: D222250, D141598, OEC 9900 Elite. MDL Numbers: D148942, D155043 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned… |
| Initiation date | Dec 27, 2016 |
| Report date | Feb 1, 2017 |
| Termination date | Jul 12, 2018 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 1720753 |
At a glance
- 1–9 Products in this recall
- 10–99 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: