device recall
saveDICOM Grid, Inc. device recall (Cls II)
November 18, 2025updated 3mo ago
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Intelerad InteleShare software, with ProViewer component — Reason: 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. — Status: Ongoing
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