FUJIFILM Synapse PACS software v7.4.310 recallZ-3030-2026 · FUJIFILM Healthcare Americas Corporation · initiated Jul 22, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software issue may cause the ruler measurement to be inaccurate.
FDA root cause category: Software design
What the company is doing
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].
Recall details
- Recall number
- Z-3030-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 22, 2026
- Posted by the FDA
- Aug 26, 2026
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 6 units
- Product code
- LLZ
- FDA submissions
- K190232
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Product description
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Code information (models, lots, serial numbers)
UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Synapse Radiology PACS Synapse Radiology PACS Software LicenseFujifilm Healthcare Americas Corporation · System, image processing, radiological9 recalls38 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page