FDA recall Z-1818-2022

DICOM Grid, Inc. d/b/a Ambra Health · Class II · device

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-06-23
Report date
2022-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1818-2022