CLASS II · ModerateFDA

DICOM Grid, Inc. recalls Intelerad InteleShare software

📅 Nov 18, 2025 · 📍 AK, AL, AR, AZ, CA, CO, CT, DE +37

Recalling company: DICOM Grid, Inc.
Product: Intelerad InteleShare software, with ProViewer component
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.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Nov 18, 2025
Reported: Dec 24, 2025
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
Status: Ongoing
Quantity: 924
Lot / codes: Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
Company location: Raleigh, NC
Recall type: Voluntary: Firm initiated
Recall number: Z-0941-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0941-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.