FDA-Device2013-04-17Class II
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
AGFA Corp.
Hazard
Software design error in IMPAX CV 7.8 SU3
Sold states
Distribute in the state of FL and KY
Affected count
2
Manufactured in
10 S Academy St, Greenville, SC, United States
Products
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2013Don't want to check this manually?
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