Fujifilm recalls PACS software versions 7.0.0 and 7.0.1 due to clinical reporting errors when ventricular traces are changed by different users. Affected users should check their software version and contact Fujifilm for updates.
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
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Contact the company
📍Recalling firmFujifilm Medical Systems U.S.A., Inc.81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
✎ GovInfoNow plain-language explainer
Fujifilm recalls two software versions (7.0.0 and 7.0.1) for PACS systems because changing ventricular traces in studies by different users can cause clinical reporting errors. This means reports might be inaccurate, potentially affecting patient care decisions. Read more at govinfonow.com/recall/63678-fujifilm-synapse-pacs-software-7-0-0-7-0-1.
“Fujifilm Synapse PACS Software 7.0.0/7.0.1: Clinical Reporting Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63678-fujifilm-synapse-pacs-software-7-0-0-7-0-1. Based on FDA recall #Z-0918-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0918-2021%22&limit=1).
Fujifilm Medical Systems U.S.A., Inc. recalled FUJIFILM Synapse PACS Software versions 7.0.0 and 7.0.1, the FDA said on Dec. 11, 2020. The software fails to update measurements in the Clinical Reporting Application when a different user changes the ventricular trace.
How to tell if you have it
Brand: Fujifilm
Product: FUJIFILM Synapse PACS Software
Versions: 7.0.0 and 7.0.1
Distribution: US Nationwide, including Maryland
The hazard
The software does not update measurements and calculations in the Clinical Reporting Application when the ventricular trace is changed in the study by a different user.
Context
GovInfoNow's records show Fujifilm Medical Systems U.S.A., Inc. has had 13 other recalls since June 15, 2017. Other recent recalls of similar products include FUJIFILM Synapse PACS Software v7.4.310 (July 22, 2026), Merge PACS Workstation Software (July 22, 2026), and GE Healthcare Centricity PACS Software (July 31, 2026).
How to tell if you have this one
Check if your Fujifilm Synapse PACS software version is 7.0.0 or 7.0.1. The software is used as a web-based application on compatible PCs connected to a Fujifilm Synapse PACS server.
Brand
Fujifilm
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your software version by checking the application settings or documentation.
Contact Fujifilm
Reach out to Fujifilm Medical Systems for guidance on updates or alternatives.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MD.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0918-2021 (December 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0918-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.