29

Jun

2016

Cl II Fujifilm Synapse PACS

0

Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report 6/29/2016
Class lI:

PRODUCT

Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
Recall Number Z-2043-2016

REASON
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The “Image Not Loaded” message displays instead

RECALLING FIRM/MANUFACTURER
Fujifilm Medical Systems U.S.A., Inc. Stamford, CT on 5/10/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
27 units

DISTRIBUTION
US Distribution to states of: CA, FL, KS, NE, NY, and PA.

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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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