FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7.4.310

Software issue may cause the ruler measurement to be inaccurate.

FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

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 hcusquality@fujifilm.com.

• FDA enforcement recordOfficial FDA database entry for Z-3030-2026
• FDA 510(k) clearance · K190232The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find FUJIFILM Healthcare Americas CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.