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U.S. Department of Health and Human Services

Class 2 Device Recall Synapse PACS

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  Class 2 Device Recall Synapse PACS see related information
Date Initiated by Firm December 11, 2020
Create Date January 22, 2021
Recall Status1 Terminated 3 on November 17, 2021
Recall Number Z-0918-2021
Recall Event ID 87083
510(K)Number K190232  
Product Classification System, image processing, radiological - Product Code LLZ
Product FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Code Information Versions 7.0.0 and 7.0.1
Recalling Firm/
Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact Jeffrey Wan
Manufacturer Reason
for Recall
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
FDA Determined
Cause 2
Software change control
Action On 12/11/2020 Fujifilm sent consignee notifications via FedEx Priority Overnight stating that there are issues with Synapse PACS Software Version 7.0.000 and 7.0.100. Fujifilm provided a work around until a hotfix is scheduled and completed.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of MD.
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 Corporation