DICOM Grid recalls InteleShare software versions 3.24.3-3:25.2 due to potential inaccurate length measurements affecting diagnostic accuracy. Affected users should contact for remedy.
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
DICOM Grid recalls specific versions of InteleShare software that could cause inaccurate length measurements during medical imaging, potentially leading to misdiagnosis. This affects users who follow the specific steps described in the hazard.
The software has a bug that causes inaccurate length measurements when specific actions are taken: viewing images in the viewer, applying multiplanar reconstruction, and manual rotation. This could lead to misdiagnosis or inappropriate follow-up care.
Medical professionals using the software for imaging analysis are most at risk. Patients using the software for diagnostic purposes may also be affected if measurements are inaccurate.
Check if you have InteleShare software versions 3.24.3 to 3.25.2, distributed starting August 28, 2024. The UDI-DI code B228INTELESHARE0 identifies the affected product.
Identify your software version by checking the version number in the InteleShare application.
Reach out to DICOM Grid for guidance on next steps after verifying your software version.
The software has a bug that could cause inaccurate measurements under specific conditions, but it does not pose an immediate risk to users.
Software versions 3.24.3 to 3.25.2, distributed starting August 28, 2024.
Check the software version in the InteleShare application; affected versions are 3.24.3 to 3.25.2.
We’ve drafted a message you can send DICOM Grid to request your refund or repair — edit it as you like.
Subject: Recall Z-0941-2026 — DICOM Grid DICOM Grid Hello, I own a DICOM Grid that is covered by recall Z-0941-2026 from DICOM Grid. 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.