FUJIFILM Healthcare recalls Synapse PACS software version 7.3.000 due to incorrect breast measurements when using Breast Tomo Series. Affected units may need correction to ensure accurate imaging results.
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 7.3.000 because it can cause incorrect breast measurements when used with Breast Tomo Series. This could lead to inaccurate medical diagnoses if not fixed.
The software version 7.3.000 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. This combination leads to incorrect breast measurements, potentially affecting diagnosis accuracy.
Healthcare providers using Synapse PACS software version 7.3.000 for medical imaging are likely affected. Patients receiving breast imaging with this software may be at risk of inaccurate results.
Check if your Synapse PACS software shows version 7.3.000. The software version is listed in the product details as 'Software Version: 7.3.000'.
Verify your Synapse PACS software version by checking the product details for 'Software Version: 7.3.000'.
The recall is for potential inaccurate breast measurements, which could affect diagnosis. However, the hazard is not described as causing serious injury, so it's considered low risk.
Check if your Synapse PACS software shows version 7.3.000 in the product details.
The recall does not specify a remedy, so you should check with FUJIFILM Healthcare for guidance on potential corrections.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1273-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1273-2024 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.
