FUJIFILM Healthcare recalls Synapse PACS software version 7.2.100 due to potential incorrect breast cancer measurements when used with specific imaging. Affected users should contact the company for updates.
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.
FUJIFILM Healthcare is recalling a specific version of their Synapse PACS medical imaging software because it can cause incorrect breast cancer measurements when used with certain imaging techniques. This could lead to inaccurate diagnosis or treatment decisions.
The software version 7.2.100 has a flaw where measurements on a 2D image without proper pixel spacing in the DICOM header can be combined with breast tomo series results to produce incorrect measurements. This could lead to inaccurate cancer detection or treatment planning.
Healthcare providers using the Synapse PACS software version 7.2.100 for medical imaging are likely affected. Patients receiving breast imaging through this software may be at risk of incorrect measurements.
Check if you have the Synapse PACS software version 7.2.100, identified by the software version number and unique device identifier (UDI) (01)854904006008(10)0702100.
Reach out to FUJIFILM Healthcare Americas Corporation for guidance on next steps.
The recall indicates a potential for incorrect measurements in breast imaging, which could affect diagnosis, but the software itself is not inherently dangerous.
Look for the software version 7.2.100 with the unique device identifier (UDI) (01)854904006008(10)0702100.
Contact FUJIFILM Healthcare Americas Corporation for instructions on how to address the issue.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1271-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1271-2024 from FUJIFILM Healthcare. 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.
