Intelerad InteleShare software — Class II medical device recall Z-0941-2026
Ongoing recall by DICOM Grid, Inc., reported 2025-12-24, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has
| Recall number | Z-0941-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DICOM Grid, Inc., Raleigh, NC, United States |
| Recall initiated | 2025-11-18 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Quantity | 924 |
| Reason classes | software |
Product
Intelerad InteleShare software, with ProViewer component
Reason for recall
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.
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-0941-2026. 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.