The wrong patient information may be displayed in the viewer or PowerJacket.
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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 specific versions of its Synapse PACS software for radiology imaging systems. This recall is because the software might show the wrong patient information in the viewer or PowerJacket, which could lead to medical errors if used in patient care. Read more at govinfonow.com/recall/63176-fujifilm-synapse-pacs-risk-of-wrong-patient-info-display.
“Fujifilm Synapse PACS: Risk of Wrong Patient Info Display.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63176-fujifilm-synapse-pacs-risk-of-wrong-patient-info-display. Based on FDA recall #Z-1348-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2021%22&limit=1).
Fujifilm Medical Systems U.S.A., Inc. recalled Synapse PACS radiological image processing systems on March 2, 2021, according to the FDA. The software may display wrong patient information. The Food and Drug Administration announced the voluntary Class II recall.
How to tell if you have it
Brand: Fujifilm Medical Systems
Product: Synapse PACS - Radiological Image Processing System
Software version: 5.1 to 5.7.200
Quantity: 839 systems
The hazard
The wrong patient information may be displayed in the viewer or PowerJacket, according to the FDA record.
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) 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 through 5.7.200 installed on your off-the-shelf PC. The software is used for radiology imaging systems and is networked with Fujifilm Synapse PACS Software (Server).
Brand
Fujif: Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Synapse PACS software version by checking the software settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 42 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 43 days 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 recall states there is a risk of displaying wrong patient information, which could lead to medical errors. However, the specific risk level is not described as causing serious injury in normal use.
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-1348-2021 (March 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1348-2021 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.