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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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