FDA Medical Device Recalls (openFDA)
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 number
- Z-1818-2022
- Recalling firm
- DICOM Grid, Inc. d/b/a Ambra Health
- Product
- Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
- Status
- Open, Classified
- Initiated
- 2022-06-23
- Posted
- 2022-09-27
- Terminated
- not on file
- 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.
- 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
- 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.
- Lot, serial or model codes
- UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
- 510(k) numbers
- ["K202335"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3008776294
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28