FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
FDA Recall Z-3030-2026 · Posted 2026-08-26
Advertisement
Recalling FirmFUJIFILM Healthcare Americas Corporation
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2026-07-22
Product Quantity6 units
Reason for Recall
Software issue may cause the ruler measurement to be inaccurate.
Firm Action
FUJIFILM 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 [email protected].
Root Cause
Software design
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement