Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports. |
|---|---|
| Recall Number | Z-2069-2012 |
| Classification | Class II |
| Code Info | Software Version: RM 2.03 to 2.08, NIV 1.0 |
| Product Distributed Qty | 6 |
| Reason For Recall | When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report. |
Event Detail
| Event Id | 62534 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | AGFA Corp. |
| City | Greenville |
| State | SC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-10 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide Distribution including IN, SC, OH, TX |
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