FDA-Device2013-04-17Class II
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
AGFA Corp.
Hazard
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
Sold states
Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.
Affected count
26
Manufactured in
10 S Academy St, Greenville, SC, United States
Products
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1070-2013Don't want to check this manually?
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