DICOM Grid, Inc. d/b/a Ambra Health Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Brand
DICOM Grid, Inc. d/b/a Ambra Health
Lot Codes / Batch Numbers
UDI-DI: AMBRHEALTHSOLUTIONS0, Software Version: 3.22.2.0 and 3.22.3.0.
Products Sold
UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
DICOM Grid, Inc. d/b/a Ambra Health is recalling Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnos due to A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm distributed an Urgent Medical Device Recall Notice dated June 23, 2022, by email to affected customers. The firm informed customers that a race condition was identified between Ambra's storage system and the serivces database which has the potential to revert edits made to patient health information upon first ingestion of a study. This could lead to a possibility that incorrect patient ifnormation is presented to the physician, which would impact the decision making in regard to patient care. Customers are asked to advise all users of the system of this issue, request a patch from Ambra to be enabled on your system, and wait until all images for a given study are ingested before manually editing patient health information in the study. Ambra's actions include the deployment of a patch that is acting as a temporary fix until a software update can be deployed to all customers, which will prevent the issue from occurring in the future.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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, WV, WI, DC, PR
Page updated: Jan 10, 2026