Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
FDA Recall Z-1818-2022 · Posted 2022-09-27
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Recalling FirmDICOM Grid, Inc. d/b/a Ambra Health
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2022-06-23
Product Quantity671 downloads
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.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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