Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers...
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
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Quantity: 135 units
Why Was This Recalled?
Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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