Company: AGFA Corp.
Date of Enforcement Report 3/30/2011
Class ll:

PRODUCT
Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. Recall # Z-1434-2011

REASON
Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated January 27, 2011.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
107 units

DISTRIBUTION
Nationwide and Canada