Class II — DICOM GRID INC
| Recalling firm | DICOM Grid dba Ambra Health dba Intelerad Holdings USA Ltd |
|---|---|
| Registered facility | DICOM Grid (dba Ambra Health) (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 209 |
| Distribution | U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia. |
| Initiated | 2016-12-16 |
| Classified | 2017-01-18 |
| Terminated | 2017-04-07 |
| Recall number | Z-1045-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DICOM GRID INC (Z-1045-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76187/
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