FDAJune 23, 2022device
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
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.
- FDAIntelerad InteleShare software, with ProViewer component2025-11-18
- 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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