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.
FDA Recall Z-2069-2012 · Posted 2012-07-24
Advertisement
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-07-10
Date Terminated2013-10-29
Product Quantity6
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.
Firm Action
AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180.
For questions regarding this recall call 864-421-1754.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution including IN, SC, OH, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement