AGFA Healthcare Corp. recalls IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allow…

Recall date

December 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2652-2017

FDA classification

Class II

Brand / firm

AGFA Healthcare Corp.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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