Company: Olympus America Inc.
Date of Enforcement Report: 10/22/03
Class: II

PRODUCT
Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04.

REASON
Software malfunction; potential for simultaneous cross-linking of exam images to another patient’s file.

CODE
Versons 6.0 through 6.4.1 (excluding version 6.3.8).

RECALLING FIRM/MANUFACTURER
Olympus America Inc., Melville, NY, by letters dated August 19, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,014.

DISTRIBUTION
Nationwide, Puerto Rico, Canada, Mexico, Ecuador and Chile.