Jun

2003

Inc. Class II Fujifilm Medical System USA

Company:Fujifilm Medical System USA, Inc.
Date of Enforcement Report: 6/25/03
Class: II

PRODUCT
Synapse. Recall # Z-0932-03.

REASON
Synapse Version 2.2.1 and 2.3.1software (Free-Hand Region) may lead to incorrect density calculations during CT scan.

CODE
Version 2.2.1 and 2.3.1.

RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter during the week of May 12, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
54 units.

DISTRIBUTION
Nationwide, Canada, Germany, Isrel, and Japan.

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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Inc. Class II Fujifilm Medical System USA

Amy Sellers

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