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AGFA Corp. recalls IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating
Recalled August 1, 2012 · FDA recall Z-2069-2012 · AGFA
Hazard
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. · FDA Class II
Units
6
Sold at
Nationwide Distribution including IN, SC, OH, TX
Description
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.
Product
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.
Manufacturer(s)
AGFA Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →