Lower riskMedical device recall · FDA · Published September 11, 2020
Fujifilm Synapse PACS Software 5.1+ May Show Wrong Patient Info
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.
Take action
Contact the company
📍Recalling firmFujifilm Medical Systems U.S.A., Inc.81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/64310-fujifilm-synapse-pacs-software-5-1-may-show-wrong-patient.
“Fujifilm Synapse PACS Software 5.1+ May Show Wrong Patient Info.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64310-fujifilm-synapse-pacs-software-5-1-may-show-wrong-patient. Based on FDA recall #Z-0878-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2021%22&limit=1).
The FDA announced on September 11, 2020, that Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse PACS Software Versions 5.1 and higher due to a potential for displaying wrong patient information or incorrect SUV values. The agency issued recall number Z-0878-2021 for the voluntary Class II action.
The recall cites a potential for wrong patient information to be displayed in the viewer or PowerJacket. Additionally, incorrect max standard uptake values (SUV) for PET and CT studies may be returned for Siemens Modality.
Context
GovInfoNow's records show Fujifilm Medical Systems U.S.A., Inc. has 13 other recalls on record since June 15, 2017. Other recent recalls of similar products include FUJIFILM Synapse PACS Software v7.4.310 (July 22, 2026), Merge PACS Workstation Software Inaccurate Measurements (July 22, 2026), and GE Healthcare Centricity PACS Software Recall (July 31, 2026).
How to tell if you have this one
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.
Brand
Fujifilm Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Fujifilm Medical Systems U.S.A., Inc. for guidance on software updates or alternatives.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Software was distributed to medical facilities nationwide throughout the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 5 months 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-0878-2021 (September 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0878-2021 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.