Fujifilm recalls specific versions of Synapse PACS software (5.5.x and 5.7.x) due to potential incorrect 3D Tomo slider bar markers, which could lead to misdiagnosis. Affected units have unique serial numbers listed.
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
Fujifilm is recalling specific versions of its Synapse PACS software (5.5.x and 5.7.x) because incorrect markers on the 3D Tomo slider bar might cause misdiagnosis. This affects healthcare providers using the software for medical imaging.
The software may display Lateromedial (LM) and Lateromedial Oblique (LMO) orientation markers incorrectly on the 3D Tomo slider bar. This could cause the slice location or direction of images to be inaccurate, potentially leading to misdiagnosis.
Healthcare providers using Fujifilm Synapse PACS software versions 5.5.x and 5.7.x for medical imaging are most at risk. The recall targets specific serial numbers listed in the notice.
Check if your software version is 5.5.x or 5.7.x and if your serial number appears in the list provided by Fujifilm. The recall includes specific serial numbers starting with SY-01- or SY-02-.
Verify your Fujifilm Synapse PACS software version is 5.5.x or 5.7.x.
Check if your serial number matches any listed in the recall notice.
The software may display Lateromedial (LM) and Lateromedial Oblique (LMO) markers incorrectly on the 3D Tomo slider bar, which could lead to misdiagnosis.
Software versions 5.5.x and 5.7.x are affected.
Check if your serial number appears in the list of specific serial numbers provided in the recall notice.
We’ve drafted a message you can send Fujifilm to request your refund or repair — edit it as you like.
Subject: Recall Z-2471-2020 — Fujifilm Fujifilm Hello, I own a Fujifilm that is covered by recall Z-2471-2020 from Fujifilm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
