Drug recall
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2…
FDA recall event 75012 · Class II · Biosense Webster, Inc.
Key facts
| Event ID | 75012 |
|---|---|
| Recall numbers | Z-2776-2016 |
| Recalling firm | Biosense Webster, Inc. |
| Product type | Devices |
| Products | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical… |
| Initiation date | Aug 15, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Jan 20, 2017 |
| City | Irwindale |
| State | CA |
| Country | United States |
| FEI number | 3003113629 |
At a glance
- 1–9 Products in this recall
- 1–9 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: