Drug recall
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4…
FDA recall event 61611 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 61611 |
|---|---|
| Recall numbers | Z-0754-2013 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded… |
| Initiation date | May 24, 2012 |
| Report date | Feb 6, 2013 |
| Termination date | Jan 16, 2014 |
| 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: