Company: AGFA Corp.,
Date of Enforcement Report:8/2/2006
Class:lIl

PRODUCT
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1256-06

REASON
Possible corrupted image appearing after System Start.

CODE
All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed

RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by firm representative visit for software upgrade, on June 30, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
NY