Apr

2013

Cl ll IMPAX CV 7.8 SU3

Company:AGFA Corp. .
Date of Enforcement Report 4/17/2013
Class ll:

PRODUCT

IMPAX CV 7.8 SU3 – OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. Recall Number Z-1069-2013

REASON
Software design error in IMPAX CV 7.8 SU3

RECALLING FIRM/MANUFACTURER
AGFA Corp. Greenville, SC, on 3/15/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2

DISTRIBUTION
FL and KY

___________________________________

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 7.8 SU3

Amy Sellers

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