FUJIFILM Healthcare recalls Synapse PACS software version 7.2.200 due to incorrect breast cancer measurements when used with certain imaging. Affected users should contact 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 diagnoses if the software is still in use.
The software version 7.2.200 can produce incorrect measurements when a Secondary Capture 2D image (without pixel spacing in the DICOM header) is combined with a Breast Tomo Series. This error could lead to inaccurate breast cancer assessments.
Healthcare providers using the Synapse PACS software version 7.2.200 for medical imaging are likely affected. Patients receiving breast imaging with this software may be at risk of inaccurate results.
Check if you have the Synapse PACS software version 7.2.200, identified by software version number 7.2.200 and UDI (01)854904006008(10)0702200. The software was sold through healthcare providers.
Reach out to FUJIFILM Healthcare Americas Corporation for guidance on the recall.
The recall indicates a potential for incorrect breast measurements, but the software is not considered immediately dangerous. Users should follow the manufacturer's instructions.
Check for software version 7.2.200 with UDI (01)854904006008(10)0702200, which was sold through healthcare providers.
Contact FUJIFILM Healthcare Americas Corporation for instructions on the recall process.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1272-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1272-2024 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.
