Use cautionMedical device recall · FDA · Published January 3, 2024
FUJIFILM Synapse Cardiology PACS Software Recalled: Risk of Misdiagnosis
FUJIFILM Healthcare recalls specific versions of Synapse Cardiology PACS software due to potential incorrect left ventricle mass calculations, which could lead to misdiagnosis or incorrect treatment.
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
“FUJIFILM Synapse Cardiology PACS Software Recalled: Risk of Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56415-fujifilm-synapse-cardiology-pacs-software-recalled-risk-of-misdiagnosis. Based on FDA recall #Z-1171-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1171-2024%22&limit=1).
The FDA announced on Jan. 3, 2024, that FUJIFILM Healthcare Americas Corporation is recalling Synapse Cardiology PACS V7.3.0, V7.2, V7.1, and V7.0 due to a risk of misdiagnosis. The web-based application may calculate left ventricular mass incorrectly, potentially leading to serious health consequences for patients.
According to the FDA, the LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle. If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Context
GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has 13 other recalls on record since Oct. 14, 2021. Other recent recalls of similar products include GE Healthcare Centricity PACS Software Recall (July 31, 2026), Merge PACS Workstation Software Inaccurate Measurements - Recall (July 22, 2026), and Philips Cardiac Workstation 7000: Inaccurate Heart Rate Data Risk (July 1, 2026).
How to tell if you have this one
Check if you have Synapse Cardiology PACS software versions 7.3.0, 7.2, 7.1, or 7.0. The software is a web-based application used for processing medical images.
Brand
FUJIFILM Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US domestic distribution nationwide. International distribution to Israel.
Recall number
Product, codes & lots
Quantity
Z-1171-2024
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.; UDI-DI 854904006008 Software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000
13
Z-1172-2024
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.; UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
8
Based on the official FDA remedy
What to do — step by step
Update Software
Contact FUJIFILM Healthcare to get the latest software version that fixes the issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US domestic distribution nationwide. International distribution to Israel.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1171-2024 (January 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1171-2024 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.