# FDA recall Z-1818-2022

> **DICOM Grid, Inc. d/b/a Ambra Health** · Class II · device recall initiated 2022-06-23.

## 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

- **Recall number:** Z-1818-2022
- **Recalling firm:** DICOM Grid, Inc. d/b/a Ambra Health
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1818-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1818-2022. Source: US FDA. Licensed CC0.

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