Z-1818-2022Class II

Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images

Name: Z-1818-2022 Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images
Creator: DICOM Grid, Inc. d/b/a Ambra Health
Published: 2022-06-23
License: https://open.fda.gov/license/

DICOM Grid (dba Ambra Health) / initiated 2022-06-23 / Open, Classified / root cause: software

FDA source

DICOM Grid, Inc. d/b/a Ambra Health began a recall of Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images on 2022-06-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1818-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-23
Posted: 2022-09-27
Recalling firm: DICOM Grid (dba Ambra Health)
Product: Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 671 downloads
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.
Product codes and lots: UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1818-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1818-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-27

Product code LLZ

K202335Class IIAmbra ProViewerDicom Grid Inc Dba Ambra Health / cleared 2020-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)