Recall Z-1818-2022 ยท LLZ System, Image Processing, Radiological
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.
| Date | Sep 27, 2022 (initiated Jun 23, 2022) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202335 | Ambra ProViewer Dicom Grid Inc Dba Ambra Health, Sep 4, 2020 |