FUJIFILM Healthcare recalls Synapse PACS software version 7.2.000 due to potential incorrect breast cancer measurements when used with certain 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. This version can cause incorrect breast cancer measurements when used with certain imaging techniques, which could lead to inaccurate diagnoses.
The software version 7.2.000 has a flaw where measurements on a 2D image without proper pixel spacing in the DICOM header can be combined with breast tomography results. This combination may produce incorrect measurements, potentially affecting cancer diagnosis accuracy.
Healthcare providers using the Synapse PACS software version 7.2.000 for medical imaging are likely affected. Patients receiving breast imaging with this software version may be at risk of inaccurate measurements.
Check if your Synapse PACS software shows version 7.2.000. The unique device identifier (UDI) is (01)854904006008(10)0702000. This software was sold by FUJIFILM Healthcare Americas Corporation.
Verify your Synapse PACS software version is 7.2.000 by checking the software settings or documentation.
The recall indicates a potential for incorrect breast measurements, but the software itself is not considered dangerous. The risk is related to specific imaging combinations.
The recall record does not specify a fix or remedy. Users should contact FUJIFILM Healthcare for further instructions.
Healthcare providers using the Synapse PACS software version 7.2.000 for medical imaging should take action as they are the most affected.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1270-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1270-2024 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.
