FUJIFILM Healthcare recalls Synapse PACS software version 7.1.000 due to incorrect breast measurements when combining certain imaging results. 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 7.1.000 because it can cause incorrect breast measurements when used with Breast Tomo Series imaging. This could lead to inaccurate medical decisions if not corrected.
The software version 7.1.000 has a flaw where measurements from a Secondary Capture 2D image without proper pixel spacing in the DICOM header can combine incorrectly with Breast Tomo Series results. This leads to inaccurate breast measurements, potentially causing incorrect medical decisions.
Healthcare providers using the Synapse PACS software version 7.1.000 for medical imaging are likely affected. Patients receiving breast imaging through this system may be at risk of inaccurate results.
Check if you have Synapse PACS software version 7.1.000, identified by the software version number and UDI code (01)854904006008(10)0701000. This version was sold by FUJIFILM Healthcare Americas Corporation.
Reach out to FUJIFILM Healthcare Americas Corporation for guidance on the recall and potential fixes.
The recall indicates a potential for incorrect breast measurements, but the exact risk level is not specified in the official notice.
Look for the software version number 7.1.000 and the UDI code (01)854904006008(10)0701000 on your system.
The official notice does not specify a remedy, so contact FUJIFILM Healthcare Americas Corporation for further instructions.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1268-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-1268-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
