Company:AGFA Corp. .
Date of Enforcement Report 4/17/2013
Class ll:
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. Recall Number Z-1069-2013
REASON
Software design error in IMPAX CV 7.8 SU3
RECALLING FIRM/MANUFACTURER
AGFA Corp. Greenville, SC, on 3/15/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
FL and KY
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