Company: AGFA Corp.
Date of Enforcement Report 3/9/2011
Class ll:
PRODUCT
IMPAX CV Results Manager/Results Manager Administration Tool. The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices. Recall # Z-1435-2011
REASON
User could modify a measurement’s units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp. Greenville, SC, by letters dating from April 15, 2009 to August 26, 2009.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL, MT, NY, OR, SC
