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U.S. Department of Health and Human Services

Class 2 Device Recall FUJIFILM Synapse PACS Software

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  Class 2 Device Recall FUJIFILM Synapse PACS Software see related information
Date Initiated by Firm September 11, 2020
Create Date January 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-0878-2021
Recall Event ID 86532
510(K)Number K160108  
Product Classification System, image processing, radiological - Product Code LLZ
Product Synapse PACS Software Versions 5.1 and higher
Code Information Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
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
201-675-8947
Manufacturer Reason
for Recall
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
FDA Determined
Cause 2
Device Design
Action Letter was sent to all affected customers on 09/11/2020 stating the following: There have been no reported patient injuries associated with these issues. In an effort to ensure the highest level of customer satisfaction, FUJIFILM will offer an upgrade to Synapse PACS 5.7.200US to resolve these issues. Until your upgrade is scheduled and completed, you can continue to safely use Synapse PACS by following these additional instructions: 1. When selecting a patient off the PowerJacket or work list, please ensure that the patient information displayed in the viewer matches the desired patient and matches the PowerJacket. 2. If using a Siemens Modality, Max SUVs should not be used when rendering a clinical decision until the issue is corrected. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken.
Quantity in Commerce 235
Distribution Software was distributed to medical facilities nationwide throughout the U.S.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
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