Drug recall
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging…
FDA recall event 81760 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 81760 |
|---|---|
| Recall numbers | Z-0693-2019 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possible incorrect software version loaded. |
| Initiation date | Nov 15, 2018 |
| Report date | Jan 16, 2019 |
| Termination date | Jan 17, 2021 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
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: