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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/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact Jeffrey Wan
617-861-5300
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
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