Oct

2003

Olympus America Inc. Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Olympus America Inc. Class II

Amy Sellers

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