New York, NY, United States
DICOM Grid, Inc. d/b/a Ambra Health recalls
1 recall recorded since 2018, most recently on 23 June 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 June 2022
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1818-2022
- Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.