Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synapse PACS - Version 7.3.000 Recalled by FUJIFILM Healthcare Americas Corporation Due to Measurements on a Secondary Capture 2D image, that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact FUJIFILM Healthcare Americas Corporation directly.
Affected Products
Synapse PACS - Version 7.3.000
Quantity: 64 Units (44 US, 20 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report