Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3 — Class II medical device recall Z-1045-2017
Terminated recall by DICOM GRID INC, reported 2017-01-25, distributed in AZ, CA, CO, CT, FL, GA, HI, IL…. A software error caused the window/level to become the same in one series regardless if the image had differen
| Recall number | Z-1045-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DICOM GRID INC, Phoenix, AZ, United States |
| Recall initiated | 2016-12-16 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-04-07 |
| Distributed | AZ, CA, CO, CT, FL, GA, HI, IL, KS, MA, MD, MI, MN, MO, NE, NH, NJ, NV, NY, OH, PA, PR, TX, UT, VA, WA, WI |
| Countries outside the US | AT, AU, BR, CA, ES, IL, MY, SG |
| Quantity | 209 |
| Reason classes | software |
Product
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
Reason for recall
A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1045-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.