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.

Recall date

June 23, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1818-2022

FDA classification

Class II

Brand / firm

DICOM Grid, Inc. d/b/a Ambra Health

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.