Lower riskMedical device recall · FDA · Published January 10, 2024
FUJIFILM Synapse PACS Version 7.2.100: Incorrect Breast Measurements Risk
FUJIFILM Healthcare recalls Synapse PACS software version 7.2.100 due to potential incorrect breast cancer measurements when used with specific imaging. Affected users should contact the company for updates.
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
“FUJIFILM Synapse PACS Version 7.2.100: Incorrect Breast Measurements Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56335-fujifilm-synapse-pacs-version-7-2-100-incorrect-breast-measurements. Based on FDA recall #Z-1271-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1271-2024%22&limit=1).
FUJIFILM Healthcare Americas Corporation recalled Synapse PACS Version 7.2.100 software on Jan. 10, 2024, according to the FDA. The device may produce incorrect measurements on secondary capture images combined with a Breast Tomo Series.
How to tell if you have it
Brand: FUJIFILM Healthcare
Product: Synapse PACS - Version 7.2.100
Software Version: 7.2.100
UDI: (01)854904006008(10)0702100
The hazard
Measurements on a Secondary Capture 2D image that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Context
GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has 13 other recalls on record since Oct. 14, 2021. Other recent recalls of similar products include Merge PACS Workstation Software Inaccurate Measurements (July 22, 2026), Intelerad InteleShare Software Recall: Inaccurate Measurements Risk Misdiagnosis (Nov. 18, 2025) and GE Healthcare Centricity PACS Software Recall: Patient Data Mismatch Risk (July 31, 2026).
How to tell if you have this one
Check if you have the Synapse PACS software version 7.2.100, identified by the software version number and unique device identifier (UDI) (01)854904006008(10)0702100.
Brand
FUJIFILM Healthcare
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-1268-2024
Synapse PACS - Version 7.1.000; Software Version: 7.1.000; UDI: (01)854904006008(10)0701000
22 units (22 OUS)
Z-1269-2024
Synapse PACS - Version 7.1.000US; Software Version: 7.1.000US, UDI: (01)854904006008(10)0701000US
3 Units (3 US)
Z-1270-2024
Synapse PACS - Version 7.2.000; Software Version: 7.2.000, UDI: (01)854904006008(10)0702000
19 Units (7 US, 12 OUS)
Z-1271-2024
Synapse PACS - Version 7.2.100; Software Version: 7.2.100, UDI: (01)854904006008(10)0702100
35 Units (28 US, 7 OUS)
Z-1272-2024
Synapse PACS - Version 7.2.200; Software Version: 7.2.200, UDI: (01)854904006008(10)0702200
12 Units (12 US)
Z-1273-2024
Synapse PACS - Version 7.3.000; Software Version: 7.3.000, UDI: (01)854904006008(10)0703000
64 Units (44 US, 20 OUS)
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to FUJIFILM Healthcare Americas Corporation for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 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-1271-2024 (January 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1271-2024 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.