Reported Oct 5, 2022 · Ongoing
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
DICOM Grid, Inc. d/b/a Ambra Health
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. d/b/a Ambra Health · 450 Park Ave S Fl 10-111 · New York, NY · 10016-7320
Is this the product you have?
- Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
- Lot codes and dates
- UDI-DIAMBRHEALTHSOLUTIONS0
- Software Version3.22.2.0 and 3.22.3.0
- Amount recalled
- 671 downloads
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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