Lower riskMedical device recall · FDA · Published September 11, 2020
Fujifilm Synapse PACS Software 5.6.1: Possible 3D Sphere MAX Value Errors
Fujifilm recalls Synapse PACS Software Version 5.6.1 due to potential over-reporting of 3D Sphere MAX values in CT studies. Affected users should contact Fujifilm for guidance.
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
Take action
Contact the company
📍Recalling firmFujifilm Medical Systems U.S.A., Inc.81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
“Fujifilm Synapse PACS Software 5.6.1: Possible 3D Sphere MAX Value Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64306-fujifilm-synapse-pacs-software-5-6-1-possible-3d-sphere. Based on FDA recall #Z-0282-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0282-2021%22&limit=1).
The FDA announced on Sept. 11, 2020, that Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse PACS Software Version 5.6.1 due to the possibility of CT studies reporting erroneously high 3D Sphere MAX values.
How to tell if you have it
Brand: Fujifilm
Product: Synapse PACS Software Version 5.6.1
Distribution: US Nationwide, including Minnesota
The hazard
Fujifilm has identified that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to the 3D Sphere tool; other density tools are not affected.
Context
GovInfoNow's records show Fujifilm Medical Systems U.S.A., Inc. has had 13 other recalls on record since June 15, 2017. Other recent recalls of similar products include Fujifilm Synapse CV Software 6.0-6.2.1 (April 30, 2021), Fujifilm Synapse PACS (March 2, 2021), and Fujifilm Wako TASWako i30 Chip Cassette (Feb. 18, 2021). Other recent recalls of similar products include FUJIFILM Synapse PACS Software v7.4.310 (July 22, 2026).
How to tell if you have this one
Check if you have Fujifilm Synapse PACS Software Version 5.6.1 installed on an off-the-shelf PC used for medical imaging. The software is intended for web-based use with a Fujifilm Synapse PACS server.
Brand
Fujifilm
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Fujifilm
Reach out to Fujifilm Medical Systems U.S.A., Inc. for guidance on potential issues with the software version.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including in the state of Minnesota.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 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-0282-2021 (September 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0282-2021 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.