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.
Fujifilm is recalling Synapse PACS Software Version 5.6.1 because it may report higher-than-expected 3D Sphere MAX values in CT studies. This could lead to incorrect medical interpretations if not addressed.
The software may incorrectly report higher 3D Sphere MAX values in CT studies, potentially leading to misinterpretation of scan results. This issue is specific to the 3D Sphere tool and does not affect other density tools.
Healthcare facilities using Fujifilm Synapse PACS Software Version 5.6.1 for CT studies are likely affected. Medical professionals handling these scans face the highest risk.
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.
Reach out to Fujifilm Medical Systems U.S.A., Inc. for guidance on potential issues with the software version.
No, this issue is specific to the 3D Sphere tool and does not affect other density tools in the software.
Check if you have Fujifilm Synapse PACS Software Version 5.6.1 installed on an off-the-shelf PC used for medical imaging.
Contact Fujifilm Medical Systems U.S.A., Inc. for guidance on potential issues and next steps.
We’ve drafted a message you can send Fujifilm to request your refund or repair — edit it as you like.
Subject: Recall Z-0282-2021 — Fujifilm Fujifilm Hello, I own a Fujifilm that is covered by recall Z-0282-2021 from Fujifilm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
