Ambra PACS — Class II medical device recall Z-1818-2022
Ongoing recall by DICOM Grid, Inc. d/b/a Ambra Health, reported 2022-10-05, distributed in AR, CA, CO, CT, DC, DE, FL, GA…. A race condition between the storage system and services database has the potential to revert edits made to pa
| Recall number | Z-1818-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DICOM Grid, Inc. d/b/a Ambra Health, New York, NY, United States |
| Recall initiated | 2022-06-23 |
| Classified | 2022-09-27 |
| Reported by FDA | 2022-10-05 |
| Distributed | AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV |
| Quantity | 671 downloads |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1818-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.