Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x Recall: Incorrect 3D Tomo Slider
Fujifilm recalls specific versions of Synapse PACS software (5.5.x and 5.7.x) due to potential incorrect 3D Tomo slider bar markers, which could lead to misdiagnosis. Affected units have unique serial numbers listed.
Lower-risk recall
Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis
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What happened, in plain English
Fujifilm is recalling specific versions of its Synapse PACS software (5.5.x and 5.7.x) because incorrect markers on the 3D Tomo slider bar might cause misdiagnosis. This affects healthcare providers using the software for medical imaging. Read more at govinfonow.com/recall/65101-fujifilm-synapse-pacs-software-version-5-5-x-and-5.
Source Summary by GovInfoNow · govinfonow.com/recall/65101-fujifilm-synapse-pacs-software-version-5-5-x-and-5 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2471-2020
Cite this page
“Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x Recall: Incorrect 3D Tomo Slider.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65101-fujifilm-synapse-pacs-software-version-5-5-x-and-5. Based on FDA recall #Z-2471-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2471-2020%22&limit=1).
Why it’s dangerous
The software may display Lateromedial (LM) and Lateromedial Oblique (LMO) orientation markers incorrectly on the 3D Tomo slider bar. This could cause the slice location or direction of images to be inaccurate, potentially leading to misdiagnosis.
Who’s affected
Healthcare providers using Fujifilm Synapse PACS software versions 5.5.x and 5.7.x for medical imaging are most at risk. The recall targets specific serial numbers listed in the notice.
How to tell if you have this one
Check if your software version is 5.5.x or 5.7.x and if your serial number appears in the list provided by Fujifilm. The recall includes specific serial numbers starting with SY-01- or SY-02-.
- Brand
Fujifilm- Category
Medical device
What to do — step by step
Check Software Version
Verify your Fujifilm Synapse PACS software version is 5.5.x or 5.7.x.
Review Serial Numbers
Check if your serial number matches any listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2471-2020 (May 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2471-2020 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.