FUJIFILM Healthcare recalls Synapse PACS software version 7.1.000US due to incorrect breast measurements when using specific imaging features. 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 Synapse PACS software version 7.1.000US because it can cause incorrect breast measurements when used with certain imaging features. This could lead to inaccurate medical diagnoses if not corrected.
The software may produce incorrect breast measurements when combining a Secondary Capture 2D image without proper pixel spacing in the DICOM header with a Breast Tomo Series. This could lead to inaccurate medical assessments if not corrected.
Healthcare providers using Synapse PACS software version 7.1.000US for medical imaging. Those performing breast tomography scans are most at risk of inaccurate measurements.
Check if your Synapse PACS software shows version 7.1.000US. The UDI code (01)854904006008(10)0701000US is also associated with this version.
Reach out to FUJIFILM Healthcare for guidance on correcting the issue with your software version.
The recall is for potential inaccurate breast measurements, which could affect medical diagnoses. However, the hazard is not described as causing serious injury, so it's considered low risk.
Check if your Synapse PACS software version is 7.1.000US, with the UDI code (01)854904006008(10)0701000US.
Contact FUJIFILM Healthcare for instructions on correcting the issue with your software version.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1269-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1269-2024 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.
