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 | Ongoing |
| Reason | Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up. |
| Product | Intelerad InteleShare software, with ProViewer component |
| Quantity | 924 |
| Distribution | US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA, WV, MN, KS, MD, VT, IA, RI, AL, ID, LA, PR, NH, IN, OK, UT, NE, SC, AR, DE OUS: CA, NZ, AU, GB, BE, FR, IT, NO, SE |
| Initiated | 2025-11-18 |
| Classified | 2025-12-18 |
| Recall number | Z-0941-2026 |
| 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-0941-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97993/
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