Company:AGFA Corp.
Date of Enforcement Report 12/21/11
Class ll:

PRODUCT
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0272-2012

REASON
Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 6, 2011.
Manufacturer: AGFA HealthCare Corp., Westerly, RI. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
323 units

DISTRIBUTION
Nationwide and Canada