Reported Dec 24, 2025 · Ongoing
Intelerad InteleShare software, with ProViewer component
DICOM Grid, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DICOM Grid, Inc. · 305 Church At North Hills St · Raleigh, NC · 27609-5177
Is this the product you have?
- Intelerad InteleShare software, with ProViewer component
- Lot codes and dates
- Software versions 3.24.3 - 3.25.2
- Date of First Distribution2024-08-28
- UDI-DIB228INTELESHARE0
- Amount recalled
- 924
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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