Z-3030-2026Class II

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

Name: Z-3030-2026 FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2026-07-22
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2026-07-22 / Open, Classified / root cause: software

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of FUJIFILM Synapse PACS software v7.4.310; radiological image processing system on 2026-07-22. FDA classified it as Class II and gives the reason as "Software issue may cause the ruler measurement to be inaccurate". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3030-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-22
Posted: 2026-08-26
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software issue may cause the ruler measurement to be inaccurate.
Root cause tag: software
FDA 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 (1-888-385-4633) 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].
Quantity in commerce: 6 units
Distribution: Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Product codes and lots: UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3030-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3030-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26

Product code LLZ

K190232Class IISynapse PACSFujifilm Corporation / cleared 2019-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)