Drug recall
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500…
FDA recall event 62112 · Class I · GE OEC Medical Systems, Inc
Key facts
| Event ID | 62112 |
|---|---|
| Recall numbers | Z-1985-2012 |
| Recalling firm | GE OEC Medical Systems, Inc |
| Product type | Devices |
| Products | InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare… |
| Initiation date | Sep 15, 2006 |
| Report date | Jul 18, 2012 |
| Termination date | Aug 21, 2012 |
| 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: