Fujifilm recalls Synapse PACS software versions 5.1 and higher due to risk of displaying incorrect patient information or SUV values in medical imaging. Affected users should contact the manufacturer for updates.
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
Fujifilm is recalling its Synapse PACS software versions 5.1 and higher because it may show wrong patient information or incorrect maximum standard uptake values for PET scans. This could lead to misdiagnosis if the software displays inaccurate data during medical imaging.
The software may display incorrect patient information in the viewer or PowerJacket, which could lead to misdiagnosis. Additionally, it might return incorrect maximum standard uptake values for PET scans, potentially affecting treatment decisions.
Healthcare providers using Fujifilm Synapse PACS software versions 5.1 and higher are likely affected. Medical staff handling imaging data may be at risk if the software displays incorrect patient information.
Check if you have Fujifilm Synapse PACS software versions 5.1, 5.2, 5.3, 5.4, 5.5, or 5.7. The software is used in medical imaging systems for viewing patient scans.
Reach out to Fujifilm Medical Systems U.S.A., Inc. for guidance on software updates or alternatives.
Software versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
The software may display incorrect patient information or return wrong maximum standard uptake values for PET scans, potentially leading to misdiagnosis.
No immediate stop is required; contact Fujifilm for updates or alternatives.
We’ve drafted a message you can send Fujifilm Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0878-2021 — Fujifilm Medical Systems Fujifilm Medical Systems Hello, I own a Fujifilm Medical Systems that is covered by recall Z-0878-2021 from Fujifilm Medical Systems. 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.
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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.
