Company:AGFA Corp.
Date of Enforcement Report 8/112
Class ll:
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. Recall Number Z-2069-2012
REASON
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.
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC on 7/10/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
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