Device product
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Z-1818-2022
Product summary
- 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
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.