Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to There was a case that the swivel arm...
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 Medical Systems U.S.A., Inc. directly.
Affected Products
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Quantity: 15 US 1 OUS
Why Was This Recalled?
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Where Was This Sold?
US Distribution and Internationally to Mexico.
About Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report