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U.S. Department of Health and Human Services

Class 2 Device Recall FUJIFILM Synapse

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 Class 2 Device Recall FUJIFILM Synapsesee related information
Date Initiated by FirmJuly 22, 2026
Date PostedAugust 26, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3030-2026
Recall Event ID 99529
510(K)NumberK190232 
Product Classification System, image processing, radiological - Product Code LLZ
ProductFUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Code Information UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
FEI Number 1000513161
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactKotei Aoki
765-246-2931
Manufacturer Reason
for Recall		Software issue may cause the ruler measurement to be inaccurate.
FDA Determined
Cause 2		Software design
ActionFUJIFILM issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 7/21/2026 via email. The notice explained the issue and how to identify it, risk to health, and requested the following: "ACTIONS TO BE TAKEN BY THE CUSTOMER/END-USER 1. Please post this notification on or near the Synapse PACs workstation. 2. 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. 3. Please contact Technical Assistance Center (TAC) at 1-888-FUJIMED (1-888-385-4633) to open a service ticket. 4. Please report any known adverse events to FDA via MedWatch. Regarding this issue, Synapse PACS can safely be used by the end-user as long as: 5. The end-user is aware of the issue and, 6. Appropriate actions are taken when rendering a diagnosis for patients. The following workarounds can be used: 7. Perform M-mode ruler measurements on the ultrasound system and then transfer the study to Synapse PACS." For questions regarding this notice, please email hcusquality@fujifilm.com.
Quantity in Commerce6 units
DistributionWorldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
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
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