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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 PACSsee related information
Date Initiated by FirmFebruary 11, 2025
Date PostedMarch 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1407-2025
Recall Event ID 96360
510(K)NumberK160108 K190232 
Product Classification System, image processing, radiological - Product Code LLZ
ProductSynapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Code Information Model numbers: Synapse PACS 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200 Software Version Numbers: Synapse PACS 7.4.000, UDI: (01)00854904006008(10)0704000; Synapse PACS 7.4.001, UDI: (01)00854904006008(10)0704001; Synapse PACS 7.4.010, UDI: (01)00854904006008(10)0704010; Synapse PACS 7.4.100, UDI: (01)00854904006008(10)0704100; Synapse PACS 7.4.110, UDI: (01)00854904006008(10)0704110; Synapse PACS 7.4.200, UDI: (01)00854904006008(10)0704200.
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactKotei Aoki
617-861-5300
Manufacturer Reason
for Recall		The incorrect computed patient age is showing in VX for patients less than 3 months old.
FDA Determined
Cause 2		Software change control
ActionOn February 11, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. ACTIONS TO BE TAKEN BY THE COMPANY Fujifilm will issue corrections for all impacted 7.4.x versions. The following patch releases will be made available: - 7.4.020 for 7.4.0x versions (immediately available) - 7.4.120 for 7.4.1x versions (available February 28, 2025) - 7.4.210 for 7.4.2x versions (available February 28,2025) ACTIONS THAT CAN BE TAKEN BY THE END-USER IMMEDIATELY Regarding this issue, Synapse PACS VX can safely be used by the end-user as long as; 1] the end-user is aware of the issue and, 2] takes appropriate actions when rendering a diagnosis for patients under 18 years of age. The following workarounds can be used: 1) The image acquisition date and date of birth are displayed on the Image. The end-user can use the dates to verify the age or, 2) Open the Series Viewer by double clicking on the thumbnail displayed on top the Synapse VX Image viewing window or the worklist. The Series Viewer Window will render the image on the server using the Server-side rendering (Zero Viewer component) which will calculate the age correctly. Alternatively, the user can switch to the Synapse PACS Zero Viewer/Thin Viewer (Server-side Rendering). The Synapse PACS Zero Viewer/Thin Viewer calculates the age correctly. ACTIONS TO BE TAKEN BY THE CUSTOMER/END-USER 1) Please complete and return the Field Action Verification Form attached to this communication. Responding with the information requested is essential for ensuring appropriate action is taken. 2) Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to schedule a patch update. Fujifilm regrets any inconvenience this action may cause and appreciates your understanding and cooperation. Please contact our field action coordinator, Jay Wigley, via email at hcusquality@fujifilm.com, if you have any further questions regarding this field action. Please contact Technical Assistance Center (TAC) at 1-888-385-4622 or 1-888-FU
Quantity in Commerce104 units (69 US, 35 OUS)
DistributionDomestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
510(K)s with Product Code = LLZ
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