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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