FDA Device recall Z-1818-2022
Ambra PACS, Ambra ProViewer
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of Ambra PACS, Ambra ProViewer by Dicom Grid, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1818-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-23 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dicom Grid |
| Distribution | 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 |
Product
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
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.
Identifiers
| code_info | UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1818-2022%22
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