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.
FDA Recall Z-2043-2016 · Posted None
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Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-05-10
Date Terminated2019-02-20
Product Quantity27 units
Reason for Recall
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Firm 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 .
Root Cause
Software design
Distribution Pattern
US Distribution to states of: CA, FL, KS, NE, NY, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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