DICOM Grid, Inc.: Intelerad InteleShare software, with ProViewer component
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- DICOM Grid, Inc.
- Product
- Intelerad InteleShare software, with ProViewer component
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2025-11-18
- Code info
- Software versions 3.24.3 - 3.25.2. Date of First Distribution: 2024-08-28. UDI-DI: B228INTELESHARE0
- Product quantity
- 924
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Raleigh
- State
- NC
- Country
- United States
- Event id
- 97993
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