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AGFA Corp. recalls IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digita
Recalled April 17, 2013 · FDA recall Z-1069-2013 · AGFA
Hazard
Software design error in IMPAX CV 7.8 SU3 · FDA Class II
Units
2
Sold at
Distribute in the state of FL and KY
Description
Software design error in IMPAX CV 7.8 SU3
Product
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.
Manufacturer(s)
AGFA Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →