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Recall Observatory FDA recall evidence

Device product

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

Z-1818-2022

June 23, 2022

Class II

Product summary

Firm
DICOM Grid, Inc. d/b/a Ambra Health
Event
Event 90817
Status
Ongoing
Classification
Class II
Quantity
671 downloads
Official record key
device-enforcement:Z-1818-2022

Official wording

Reason: 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.

Code information: UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.