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Lower risk Medical device recall · FDA · Published February 11, 2025

FUJIFILM Synapse PACS Software 7.4.x: Incorrect Patient Age Display Risk

FUJIFILM recalls Synapse PACS software versions 7.4.000-7.4.200 due to incorrect patient age calculations for infants under 3 months old. Affected users should verify their software version.

🇺🇸 FDA recall #Z-1407-2025Medical deviceFUJIFILM Healthcare ›
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Contact the company

Recalling firmFUJIFILM Healthcare Americas Corporation81 Hartwell Ave Ste 300 · Lexington, MA 02421-3160
✎ GovInfoNow plain-language explainer

What happened, in plain English

FUJIFILM is recalling specific versions of their Synapse PACS medical imaging software because it shows incorrect patient ages for infants under 3 months old. This could lead to improper medical treatment decisions if the age is used in patient care. Read more at govinfonow.com/recall/52913-fujifilm-synapse-pacs-software-7-4-x-incorrect-patient-age.

Source Summary by GovInfoNow · govinfonow.com/recall/52913-fujifilm-synapse-pacs-software-7-4-x-incorrect-patient-age · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1407-2025

Cite this page

“FUJIFILM Synapse PACS Software 7.4.x: Incorrect Patient Age Display Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52913-fujifilm-synapse-pacs-software-7-4-x-incorrect-patient-age. Based on FDA recall #Z-1407-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1407-2025%22&limit=1).

Why it’s dangerous

The software incorrectly calculates patient age for infants under 3 months old, which could result in inappropriate medical decisions if the incorrect age is used in patient care. This is a data error rather than a physical hazard.

Who’s affected

Healthcare facilities using Synapse PACS software versions 7.4.000 through 7.4.200 are affected. Medical staff handling infant patient records are most at risk of potential treatment errors.

How to tell if you have this one

Check your Synapse PACS software version number. Affected versions are 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, and 7.4.200. The UDI codes are listed in the recall notice for identification.

  • Brand
    FUJIFILM Healthcare
  • Product
    Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your Synapse PACS software version to see if it matches the affected versions listed in the recall.

Where it went and when

Where it was distributed

Distributed in 30 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: yesWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: not listedALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Tennessee, Texas, Vermont, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Feb 11, 202512. FDA classified it Class II: Mar 20, 202523. Published in FDA’s Enforcement Report: Mar 26, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1407-2025 (February 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1407-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA