Jul

2017

IMPAX CV Reporting module Cl II

Company: AGFA Healthcare Corp..
Date of Enforcement Report 7/5/2017
Class lI:

PRODUCT

IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Recall Number Z-2652-2017

REASON
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm..

RECALLING FIRM/MANUFACTURER
AGFA Healthcare Corp., Greenville, SC on 12/22/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
10

DISTRIBUTION
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

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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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IMPAX CV Reporting module Cl II

Amy Sellers

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