Company: AGFA Corp
Date of Enforcement Report 7/9/2008
Class:ll

PRODUCT
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning, Z-1307-2008

REASON
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.

RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letters on February 17, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
879 units

DISTRIBUTION
Nationwide and Canada