DICOM Grid, Inc. recalls Intelerad InteleShare software, with ProViewer component

Recall date

November 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0941-2026

FDA classification

Class II

Brand / firm

DICOM Grid, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Intelerad InteleShare software, with ProViewer component