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All product recalls associated with FUJIFILM Healthcare Americas Corporation.
Total Recalls
1000
Past Year
1000
Class I (Serious)
143
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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.
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
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.