Aug

2012

Cl ll IMPAX CV Reporting The Results Management

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll IMPAX CV Reporting The Results Management

Amy Sellers

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