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AGFA Healthcare Corp. recalls IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allow
Recalled July 5, 2017 · FDA recall Z-2652-2017 · AGFA Healthcare
Hazard
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. · FDA Class II
Units
10
Sold at
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
Description
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.
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
Manufacturer(s)
AGFA Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →