Company:AGFA Corp. .
Date of Enforcement Report 4/17/2013
Class ll:
PRODUCT
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Recall Number Z-1070-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
AGFA Corp. Greenville, SC, on 3/15/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
26
DISTRIBUTION
Nationwide
___________________________________
