Intelerad InteleShare software, with ProViewer component
FDA Recall #Z-0941-2026 — Class II — November 18, 2025
Product Description
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.
Recalling Firm
DICOM Grid, Inc. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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
Code Information
Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated