Drug recall
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review…
FDA recall event 61612 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 61612 |
|---|---|
| Recall numbers | Z-0125-2013 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential… |
| Initiation date | May 24, 2012 |
| Report date | Oct 31, 2012 |
| Termination date | Dec 11, 2012 |
| 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: