FDA-Device2017-07-05Class II
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
AGFA Healthcare Corp.
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.
Sold states
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
Affected count
10
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2652-2017Don't want to check this manually?
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