DICOM Grid, Inc.: Device Recall
Recall #Z-0941-2026 · 11/18/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0941-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DICOM Grid, Inc.
- Status
- Ongoing
- Date Initiated
- 11/18/2025
- Location
- Raleigh, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 924
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.
Product Description
Intelerad InteleShare software, with ProViewer component
Distribution Pattern
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.