Company: Olympus America, Inc
Date of Enforcement Report: 8/27/03
Class: II
PRODUCT
Olympus Image Manager Software. Recall # Z-1126-03.
REASON
Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
CODE
Versions 6.0 through 6.4.
RECALLING FIRM/MANUFACTURER
Olympus America, Inc., Melville, NY, by letters, dated March 5, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
856.
DISTRIBUTION
Nationwide and Internationally.
