Drug recall
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI)…
FDA recall event 77629 · Class II · AGFA Healthcare Corp.
Key facts
| Event ID | 77629 |
|---|---|
| Recall numbers | Z-2652-2017 |
| Recalling firm | AGFA Healthcare Corp. |
| Product type | Devices |
| Products | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm. |
| Initiation date | Dec 22, 2016 |
| Report date | Jul 5, 2017 |
| Termination date | Aug 27, 2021 |
| City | Greenville |
| State | SC |
| Country | United States |
| FEI number | 3001236302 |
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: