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U.S. Department of Health and Human Services

Class 2 Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020

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  Class 2 Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020 see related information
Date Initiated by Firm May 10, 2016
Create Date June 21, 2016
Recall Status1 Terminated 3 on February 20, 2019
Recall Number Z-2043-2016
Recall Event ID 74372
510(K)Number K112439  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
419 West Ave
Stamford CT 06902-6343
For Additional Information Contact
203-324-2000
Manufacturer Reason
for Recall		 Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
FDA Determined
Cause 2		 Software design
Action The firm, FujiFilm, sent an "MEDICAL DEVICE CORRECTION" letter dated May 10, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken.The customers were instructed to: Extend the Ad hoc deletion retention period or discontinue use of Ad Hoc Deletion, and complete and submit the attached Customer Response Form to Fujifilm via fax to (203)-251-7863. Affected systems will be corrected via on-site visits by FMSU Customer Service Engineers upgrading to Version 4.4.100. Questions or concerns, contact the FUJI FILM Customer Support Center at 1- 888-FUJIMED Option #1 .
Quantity in Commerce 27 units
Distribution US Distribution to states of: CA, FL, KS, NE, NY, and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = FUJIFILM MEDICAL SYSTEM U.S.A., INC.
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