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

PRODUCT
IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0212-2012

REASON
Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR).

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

VOLUME OF PRODUCT IN COMMERCE
280 units

DISTRIBUTION
Nationwide and Canada