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DICOM Grid, Inc. d/b/a Ambra Health recalls Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Recalled October 5, 2022 · FDA recall Z-1818-2022 · DICOM Grid, Inc.
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. · FDA Class II
Units
671 downloads
Sold at
Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.
Description
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.
Product
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Manufacturer(s)
DICOM Grid, Inc. d/b/a Ambra Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →