DICOM Grid, Inc. d/b/a Ambra Health: Medical Device Recall in 2022 - (Recall #: Z-1818-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 23, 2022

Date Posted: October 5, 2022

Recall Number: Z-1818-2022

Event ID: 90817

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.

Status: Ongoing

Product Quantity: 671 downloads

Code Information:

UDI-DI: AMBRHEALTHSOLUTIONS0; Software Version: 3.22.2.0 and 3.22.3.0.

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.

Voluntary or Mandated:

Voluntary: Firm initiated