Drug recall
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version…
FDA recall event 64461 · Class II · Vital Images, Inc.
Key facts
| Event ID | 64461 |
|---|---|
| Recall numbers | Z-1002-2013 |
| Recalling firm | Vital Images, Inc. |
| Product type | Devices |
| Products | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and… |
| Initiation date | Feb 5, 2013 |
| Report date | Apr 3, 2013 |
| Termination date | May 8, 2015 |
| City | Minnetonka |
| State | MN |
| Country | United States |
| FEI number | 3001654007 |
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: