FDANovember 18, 2025device
Intelerad InteleShare software, with ProViewer component
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
dicom griddicom
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAmbra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.2022-06-23
- FDAAmbra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.2016-12-16
- CPSCWakaWaka Recalls Adapter Kits Due to Electrical Shock, Explosion, Fire Hazards (Recall Alert)2015-11-12
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