Recall Z-3030-2026 ยท LLZ System, Image Processing, Radiological
FUJIFILM Healthcare Americas Corporation
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
| Date | Aug 26, 2026 (initiated Jul 22, 2026) |
| Status | Open, Classified |
| Reason | Software issue may cause the ruler measurement to be inaccurate. |
| Root cause | Software design |
| 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 |
| Quantity | 6 units |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190232 | Synapse PACS Fujifilm Corporation, Mar 26, 2019 |