Class 2 Device Recall Ambra ProViewer

• Date Initiated by Firm: June 23, 2022
• Date Posted: September 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1818-2022
• Recall Event ID: 90817
• 510(K)Number: K202335
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
• Code Information: UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.
• FEI Number: 3008776294
• Recalling Firm/ Manufacturer: DICOM Grid, Inc. d/b/a Ambra Health; 450 Park Ave S Fl 10-111; New York NY 10016-7320
• For Additional Information Contact: Ambra Support; 888-315-0790
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ